Trial Outcomes & Findings for Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients (NCT NCT02770807)

Last Updated: 2024-05-10

Results Overview

The International Cooperative Ataxia Rating Scale (ICARS) was an assessment of the degree of impairment in patients with cerebellar ataxia and was administered in its entirety; however, the primary efficacy assessment was based on the modified (m)ICARS, which excluded the Oculomotor domain (items 17 to 19) and items 8 to 12 of the Kinetic Functions domain of the ICARS. The mICARS was a 54 points maximum score (min 0) questionnaire divided into 3 sections: * Posture and Gait Disturbance section-7 items (min score 0, max score 34) * Kinetic Function-2 items (min score 0, max score 12) * Speech Disorder- 2 items (min score 0, max score 8). The assessment was designed to be completed within 30 minutes, and higher scores - both for total and subscores - indicate a higher level of disease impairment. The subscores are added to give the total score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

176 participants

Primary outcome timeframe

to Month 6 (Visit 9)

Results posted on

2024-05-10

Participant Flow

176 patients were randomized, and 175 patients received study drug (Safety Population or ITT). There were 164 patients in the mITT and 107 patients in the PP population. Of the 164 patients in the mITT, 54 were randomized to placebo, 56 to low dose, and 54 to high dose EryDex.The PP population excluded 57 patients that were unable to comply with the study treatment interval, mainly due to the COVID-19 pandemic and issues with traveling in India, and who did not meet the definition of the PP.

Participant milestones

Participant milestones
Measure	EryDex Low Dose DSP - SAF EDS-EP dose range of \~5-10 mg DSP/infusion: Patients were treated with EryDex prepared using 2.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 13.0 mL, corresponding to 50.0 mg of experimental drug which resulted in a mean of 8.23 mg ± 3.30 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - SAF EDS-EP dose range of \~14-22 mg DSP/infusion: Patients were treated with EryDex prepared using 5.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 16 mL, corresponding to 125 mg of experimental drug which resulted in a mean of 17.4 ± 5.38 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Pooled Placebo - SAF Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (5 mL of 0.372% NaCl solution) instead of experimental drug (DSP). Placebo was diluted with 11 mL sterile water for injection in the same syringe, for a total of 16 mL. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Overall Study STARTED	59	58	59
Overall Study Participants Who Took the Study Drug	59	57	59
Overall Study Modified Intention to Treat Population - mITT	56	54	54
Overall Study Safety Population - SAF	59	57	59
Overall Study Per Protocol Population - PP	36	38	33
Overall Study Completed Visit 9	43	46	43
Overall Study Discontinued Prior to Visit 9	16	11	16
Overall Study Participants From Month 6 to Month 9	43	46	43
Overall Study Participants From Month 9 to month12	34	38	36
Overall Study COMPLETED	34	38	36
Overall Study NOT COMPLETED	25	20	23

Reasons for withdrawal

Reasons for withdrawal
Measure	EryDex Low Dose DSP - SAF EDS-EP dose range of \~5-10 mg DSP/infusion: Patients were treated with EryDex prepared using 2.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 13.0 mL, corresponding to 50.0 mg of experimental drug which resulted in a mean of 8.23 mg ± 3.30 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - SAF EDS-EP dose range of \~14-22 mg DSP/infusion: Patients were treated with EryDex prepared using 5.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 16 mL, corresponding to 125 mg of experimental drug which resulted in a mean of 17.4 ± 5.38 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Pooled Placebo - SAF Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (5 mL of 0.372% NaCl solution) instead of experimental drug (DSP). Placebo was diluted with 11 mL sterile water for injection in the same syringe, for a total of 16 mL. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Overall Study Adverse Event	3	3	1
Overall Study Withdrawal by Subject	7	3	4
Overall Study Other	0	1	0
Overall Study Covid-Related Treatment/Visit Delay	15	13	17
Overall Study Physician Decision	0	0	1

Baseline Characteristics

Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EryDex Low Dose DSP - SAF n=59 Participants EDS-EP dose range of \~5-10 mg DSP/infusion: Patients were treated with EryDex prepared using 2.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 13.0 mL, corresponding to 50.0 mg of experimental drug which resulted in a mean of 8.23 mg ± 3.30 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - SAF n=57 Participants EDS-EP dose range of \~14-22 mg DSP/infusion: Patients were treated with EryDex prepared using 5.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 16 mL, corresponding to 125 mg of experimental drug which resulted in a mean of 17.4 ± 5.38 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Pooled Placebo - SAF n=59 Participants Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (5 mL of 0.372% NaCl solution) instead of experimental drug (DSP). Placebo was diluted with 11 mL sterile water for injection in the same syringe, for a total of 16 mL. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.	Total n=175 Participants Total of all reporting groups
Age, Categorical <=18 years	59 Participants n=93 Participants	57 Participants n=4 Participants	59 Participants n=27 Participants	175 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	9.5 years STANDARD_DEVIATION 3.16 • n=93 Participants	10.2 years STANDARD_DEVIATION 4.86 • n=4 Participants	10.3 years STANDARD_DEVIATION 4.02 • n=27 Participants	10.0 years STANDARD_DEVIATION 4.06 • n=483 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	27 Participants n=4 Participants	29 Participants n=27 Participants	85 Participants n=483 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	30 Participants n=4 Participants	30 Participants n=27 Participants	90 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	25 Participants n=93 Participants	20 Participants n=4 Participants	27 Participants n=27 Participants	72 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants	36 Participants n=4 Participants	29 Participants n=27 Participants	99 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment Belgium	1 participants n=93 Participants	2 participants n=4 Participants	0 participants n=27 Participants	3 participants n=483 Participants
Region of Enrollment United States	11 participants n=93 Participants	12 participants n=4 Participants	10 participants n=27 Participants	32 participants n=483 Participants
Region of Enrollment Norway	2 participants n=93 Participants	2 participants n=4 Participants	1 participants n=27 Participants	5 participants n=483 Participants
Region of Enrollment Poland	3 participants n=93 Participants	5 participants n=4 Participants	3 participants n=27 Participants	11 participants n=483 Participants
Region of Enrollment United Kingdom	2 participants n=93 Participants	3 participants n=4 Participants	6 participants n=27 Participants	11 participants n=483 Participants
Region of Enrollment Italy	1 participants n=93 Participants	2 participants n=4 Participants	1 participants n=27 Participants	4 participants n=483 Participants
Region of Enrollment Israel	1 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants
Region of Enrollment Australia	1 participants n=93 Participants	3 participants n=4 Participants	1 participants n=27 Participants	5 participants n=483 Participants
Region of Enrollment Tunisia	3 participants n=93 Participants	3 participants n=4 Participants	2 participants n=27 Participants	8 participants n=483 Participants
Region of Enrollment Germany	5 participants n=93 Participants	6 participants n=4 Participants	5 participants n=27 Participants	16 participants n=483 Participants
Region of Enrollment Spain	7 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants	13 participants n=483 Participants
Region of Enrollment India	22 participants n=93 Participants	18 participants n=4 Participants	26 participants n=27 Participants	66 participants n=483 Participants

PRIMARY outcome

Timeframe: to Month 6 (Visit 9)

Population: Modified Intention to Treat population - mITT: ll randomized patients who received at least one dose of study medication and had at least one post-baseline efficacy assessment of the primary efficacy variable

Outcome measures

Outcome measures
Measure	EryDex Low Dose DSP - mITT n=56 Participants EDS-EP dose range of \~5-10 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - mITT n=54 Participants EDS-EP dose range of \~14-22 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Placebo - mITT n=54 Participants Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (NaCl solution) instead of experimental drug (DSP). This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Change From Baseline in Modified International Cooperative Ataxia Rating Scale (mICARS)	0.8 score on a scale Standard Deviation 3.56	1.0 score on a scale Standard Deviation 3.32	2.3 score on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: to Month 6 (Visit 9)

The CGI-C scale assesses the change in the patient's clinical status from baseline using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change. Clinicians were required to conduct a full clinical interview and examination of the patient. The interview and examination assessed various aspects of the patient's appearance (grooming, evidence of falls, etc.), ataxia, cognition (orientation, calculation ability, language, ability to follow commands, memory, etc.), apraxia, dysarthria, extrapyramidal motor symptoms, activities of daily living, and mood. The higher the score the worse the outcome.

Outcome measures

Outcome measures
Measure	EryDex Low Dose DSP - mITT n=56 Participants EDS-EP dose range of \~5-10 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - mITT n=54 Participants EDS-EP dose range of \~14-22 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Placebo - mITT n=54 Participants Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (NaCl solution) instead of experimental drug (DSP). This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Number of Patients With Improving, Stable or Worsening Score Using a Clinical Global Impression of Change (CGI-C) Improvement (Scores 1-3)	19 Participants	27 Participants	19 Participants
Number of Patients With Improving, Stable or Worsening Score Using a Clinical Global Impression of Change (CGI-C) Stable or Worsening (Scores 4-7)	37 Participants	27 Participants	35 Participants

SECONDARY outcome

Timeframe: to Visit 9 (Month 6)

The CGI-S scale measures global severity of illness at a given point in time, and is usually rated on a 7-point, Likert-type scale ranging from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). No version of the CGI-S exists which has been specifically adapted for use in patients with A-T; therefore, a 5-point version was developed that considered the severity of the following symptoms of A-T: ataxia (walking), dysarthria, dysmetria, extrapyramidal symptoms (chorea, myoclonus, dystonia, and tremor), and eye movements. Ratings of none (0), mild (1), moderate (2), severe (3), and very severe (4) were selected based on the level of symptomatology. The higher the score the worse the outcome.

Outcome measures

Outcome measures
Measure	EryDex Low Dose DSP - mITT n=56 Participants EDS-EP dose range of \~5-10 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - mITT n=54 Participants EDS-EP dose range of \~14-22 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Placebo - mITT n=54 Participants Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (NaCl solution) instead of experimental drug (DSP). This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Number of Patients With None to Severe (0 to 4) Scores in Clinical Global Impression of Severity (CGI-S)-Structured of Neurological Symptoms of AT CGI-S Score - 0	0 Participants	0 Participants	0 Participants
Number of Patients With None to Severe (0 to 4) Scores in Clinical Global Impression of Severity (CGI-S)-Structured of Neurological Symptoms of AT CGI-S Score - 1	15 Participants	16 Participants	17 Participants
Number of Patients With None to Severe (0 to 4) Scores in Clinical Global Impression of Severity (CGI-S)-Structured of Neurological Symptoms of AT CGI-S Score - 2	29 Participants	26 Participants	24 Participants
Number of Patients With None to Severe (0 to 4) Scores in Clinical Global Impression of Severity (CGI-S)-Structured of Neurological Symptoms of AT CGI-S Score - 3	12 Participants	12 Participants	13 Participants
Number of Patients With None to Severe (0 to 4) Scores in Clinical Global Impression of Severity (CGI-S)-Structured of Neurological Symptoms of AT CGI-S Score - 4	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: to Visit 9 (Month 6)

VABS-II was a questionnaire to assess adaptive behavior. It contained 4 domains each with 2-3 subdomains, every subdomain contained various items (questions): A) communication (receptive, expressive, written) B) daily living skills (personal, domestic, community) C) socialization (interpersonal relationships, play and leisure time, coping skills) D) motor skills (gross motor, fine motor). The expanded version of the VABS consisted of 540 items, 261 of which used in this trial. The possible score for each item was from 0 to 4 based on whether the patient performed the activity "never", "rarely", "sometimes", "often" or "almost always". At the end of each domain section, a total score (the sum of the score for each item) was calculated. Domain A: min score 0, max score 572. Domain B: 0 - 800. Domain C: 0 - 580. Domain D: 0 - 424. A grand total score (A+B+C+D scores) was provided (range:0-2376) The lower the score the higher the disability at each level (domains and subdomains).

Outcome measures

Outcome measures
Measure	EryDex Low Dose DSP - mITT n=56 Participants EDS-EP dose range of \~5-10 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - mITT n=52 Participants EDS-EP dose range of \~14-22 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Placebo - mITT n=52 Participants Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (NaCl solution) instead of experimental drug (DSP). This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Change From Baseline of Vineland Adaptive Behavior Scale (VABS-II) Scores - Last Observation Carried Forward (LOCF)	42.6 score on a scale Standard Deviation 125.95	-26.5 score on a scale Standard Deviation 214.52	57.5 score on a scale Standard Deviation 200.37

SECONDARY outcome

Timeframe: to Visit 9 (Month 6)

Population: Safety Population (SAF): all patients who received any amount of randomized treatment (also referred to as the ITT population).

TEAE = Treatment Emergent Adverse Events were any AEs started on or after the day of the first infusion through the day just prior to the day of the Visit 9 ("Month 6") infusion, or \<=60 days after last dose if the subject never continued past this period.

Outcome measures

Outcome measures
Measure	EryDex Low Dose DSP - mITT n=59 Participants EDS-EP dose range of \~5-10 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - mITT n=57 Participants EDS-EP dose range of \~14-22 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Placebo - mITT n=59 Participants Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (NaCl solution) instead of experimental drug (DSP). This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 6 Patients With Pre- treatment AE	14 Participants	16 Participants	14 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 6 Patients With Any TEAE	43 Participants	47 Participants	43 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 6 Patients With Any Treatment-related TEAE	15 Participants	21 Participants	15 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 6 Patients With Any Serious TEAE	6 Participants	7 Participants	7 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 6 Patients With Any Serious Treatment-related TEAE	0 Participants	1 Participants	0 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 6 Patients With Any TEAE Leading to Discontinuation	0 Participants	2 Participants	0 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 6 Patients With Any TEAE Leading to Death	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: to Visit 15 (Month 12)

Population: Safety Population: all patients who received any amount of randomized treatment (also referred to as the ITT population). Placebo patients who switched to EryDex treatment at 6 and 9 months were not added to the Extension Treatment Period safety data so that the results reported are for those patients who remained on placebo from the start of the study (N=19)

TEAE = Treatment Emergent Adverse Events were any AEs started on or after the day of the first infusion through the day just prior to the day of the Visit 15 ("Month 12") infusion. Placebo patients who switched to EryDex treatment at 6 and 9 months were not added to the Extension Treatment Period safety data so that the results reported here under are for those patients who remained on placebo from the start of the study till the end of it.

Outcome measures

Outcome measures
Measure	EryDex Low Dose DSP - mITT n=59 Participants EDS-EP dose range of \~5-10 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - mITT n=57 Participants EDS-EP dose range of \~14-22 mg DSP/infusion. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Placebo - mITT n=19 Participants Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (NaCl solution) instead of experimental drug (DSP). This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 12 Patients With Any Serious TEAE	8 Participants	9 Participants	4 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 12 Patients With Any Serious Treatment-related TEAE	1 Participants	1 Participants	1 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 12 Patients With Any TEAE	45 Participants	50 Participants	15 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 12 Patients With Any Treatment-related TEAE	19 Participants	25 Participants	5 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 12 Patients With Any TEAE Leading to Discontinuation	1 Participants	2 Participants	0 Participants
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) at Month 12 Patients With Any TEAE Leading to Death	0 Participants	0 Participants	0 Participants

Adverse Events

EryDex Low Dose DSP - SAF

Serious events: 8 serious events

Other events: 45 other events

Deaths: 0 deaths

EryDex High Dose DSP - SAF

Serious events: 9 serious events

Other events: 50 other events

Deaths: 0 deaths

Non-switch Placebo - SAF

Serious events: 4 serious events

Other events: 15 other events

Deaths: 1 deaths

Placebo Patients Switch to Low Dose - Month 6

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Patients Switch to High Dose - Month 6

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Patients Switch to Low Dose - Month 9

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Patients Switch to High Dose - Month 9

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EryDex Low Dose DSP - SAF n=59 participants at risk EDS-EP dose range of \~5-10 mg DSP/infusion: Patients were treated with EryDex prepared using 2.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 13.0 mL, corresponding to 50.0 mg of experimental drug which resulted in a mean of 8.23 mg ± 3.30 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - SAF n=57 participants at risk EDS-EP dose range of \~14-22 mg DSP/infusion: Patients were treated with EryDex prepared using 5.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 16 mL, corresponding to 125 mg of experimental drug which resulted in a mean of 17.4 ± 5.38 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Non-switch Placebo - SAF n=19 participants at risk Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (5 mL of 0.372% NaCl solution) instead of experimental drug (DSP). Placebo was diluted with 11 mL sterile water for injection in the same syringe, for a total of 16 mL. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.	Placebo Patients Switch to Low Dose - Month 6 n=9 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex low dose at Month 6 - Visit 9. (N=9)	Placebo Patients Switch to High Dose - Month 6 n=9 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex High dose at Month 6 - Visit 9. (N=9)	Placebo Patients Switch to Low Dose - Month 9 n=11 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex low dose at Month 9 - Visit 12 . (N=11)	Placebo Patients Switch to High Dose - Month 9 n=11 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex low dose at Month 9 - Visit 12. (N=11)
Blood and lymphatic system disorders Anaemia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	1.8% 1/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Congenital, familial and genetic disorders Hepato-Lenticular Degeneration	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Vomiting	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
General disorders Pyrexia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	1.8% 1/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Herpes Zoster	1.7% 1/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Lower respiratory tract infection	1.7% 1/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Pneumonia	1.7% 1/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Sepsis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	1.8% 1/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Bacterial test positive	6.8% 4/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	10.5% 6/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	15.8% 3/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Juvenile idiophatic arthritis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell limphoma	1.7% 1/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Dystonia	1.7% 1/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	1.7% 1/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Vascular disorders Aortic stenosis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	1.8% 1/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.

Other adverse events

Other adverse events
Measure	EryDex Low Dose DSP - SAF n=59 participants at risk EDS-EP dose range of \~5-10 mg DSP/infusion: Patients were treated with EryDex prepared using 2.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 13.0 mL, corresponding to 50.0 mg of experimental drug which resulted in a mean of 8.23 mg ± 3.30 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product Low dose DSP EryDex Low dose DSP: EDS-EP dose range of \~5-10 mg DSP/infusion	EryDex High Dose DSP - SAF n=57 participants at risk EDS-EP dose range of \~14-22 mg DSP/infusion: Patients were treated with EryDex prepared using 5.0 mL of the 25 mg/mL DSP solution, plus 11 mL sterile water for injection in the same syringe, for a total of 16 mL, corresponding to 125 mg of experimental drug which resulted in a mean of 17.4 ± 5.38 mg (mean ± standard deviation) of DSP infused to subjects. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period).Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Other Names: EryDex System end product High dose DSP EryDex High dose DSP: EDS-EP dose range of \~14-22 mg DSP/infusion	Non-switch Placebo - SAF n=19 participants at risk Patients were treated with autologous erythrocytes prepared with the EDS process using a placebo solution (5 mL of 0.372% NaCl solution) instead of experimental drug (DSP). Placebo was diluted with 11 mL sterile water for injection in the same syringe, for a total of 16 mL. This study treatment was to be administered by IV infusion once per month for 12 consecutive months (6 months Initial Treatment Period + 6 months Extension Treatment Period). Each patient underwent a 30-day Screening Period, during which any previous treatments with other corticosteroid compounds were withdrawn (washout from previous treatment). Pooled Placebo: EDS processed autologous erythrocytes using 5 mL of 0.372% sodium chloride \[NaCl\] solution.	Placebo Patients Switch to Low Dose - Month 6 n=9 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex low dose at Month 6 - Visit 9. (N=9)	Placebo Patients Switch to High Dose - Month 6 n=9 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex High dose at Month 6 - Visit 9. (N=9)	Placebo Patients Switch to Low Dose - Month 9 n=11 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex low dose at Month 9 - Visit 12 . (N=11)	Placebo Patients Switch to High Dose - Month 9 n=11 participants at risk Patients originally randomized to the Placebo group (Pooled Placebo) re-allocated in EryDex low dose at Month 9 - Visit 12. (N=11)
Blood and lymphatic system disorders Anemia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Congenital, familial and genetic disorders Hepato-lenticular degeneration	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Congenital, familial and genetic disorders Talipes	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Ear and labyrinth disorders Ear congestion	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Ear and labyrinth disorders Ear Pain	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Ear and labyrinth disorders Otorrhoea	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Ear and labyrinth disorders Tympanic membrane scarring	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Eye disorders Astigmatism	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Eye disorders Eye movement disorder	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Eye disorders Papilloedema	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Abdominal Pain	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	7.0% 4/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Abnormal faeces	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Anal prurirus	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Constipation	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Diarrhoea	13.6% 8/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	10.5% 6/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	26.3% 5/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	27.3% 3/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Dyspepsia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Enterocolitis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Nausea	6.8% 4/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	7.0% 4/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Teething	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Toothache	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Gastrointestinal disorders Vomiting	22.0% 13/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	19.3% 11/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	15.8% 3/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
General disorders Catheter site pain	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
General disorders Extravasation	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
General disorders Fatigue	6.8% 4/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
General disorders Malaise	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
General disorders Pyrexia	25.4% 15/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	33.3% 19/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	15.8% 3/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	33.3% 3/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	22.2% 2/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	36.4% 4/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
General disorders Swelling	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Hepatobiliary disorders Liver disorder	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	10.5% 2/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Immune system disorders Seasonal allergy	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Acarodermatitis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Bronchitis	6.8% 4/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	3.5% 2/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Conjuntivitis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Croup infectious	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Cystitis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Ear infection	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Folliculitis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Gastroenteritis	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	8.8% 5/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	10.5% 2/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Gastroenteritis viral	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Impetigo	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Influenza	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	7.0% 4/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Laryngitis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Lower respiratory tract infection	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Molluscum contagiosum	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Nasopharyngitis	16.9% 10/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	19.3% 11/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	26.3% 5/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Oral herpes	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Otitis externa	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Otitis media	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Otitis media acute	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Pneumonia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Respiratory tract infection	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Rhinitis	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Sinusitis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Upper respiratory tract infection	13.6% 8/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	15.8% 9/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Urinary tract infection	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Varicella	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Infections and infestations Wound infection	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Contusion	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Fall	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Incision site haemorrhage	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Joint injury	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Scar	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Alanine aminotransferase increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Aspartate aminotransferase increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Bacterial test positive	16.9% 10/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	17.5% 10/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	21.1% 4/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	22.2% 2/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	27.3% 3/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Blood bilirubin increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Blood cholesterol increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Blood iron decreased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Blood lactate dehidrogenase increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Blood potassium increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Blood triglycerides increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Body temperature increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Bone density decreased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Chest expansion decreased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Haemoglobin decreased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Low density lipoprotein increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Platelet count increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Respiratory rate increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Vitamin D decreased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Weight decreased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations Weight increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	1.8% 1/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	22.2% 2/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Investigations White blood cell count increased	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Metabolism and nutrition disorders Hypertrygliceridaemia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Metabolism and nutrition disorders Increased appetite	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Metabolism and nutrition disorders Insulin resistance	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Metabolism and nutrition disorders Iron deficiency	10.2% 6/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	8.8% 5/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Juvenile idiopathic arthritis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Muscoskeletal discomfort	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Musculoskeletal stifness	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	7.0% 4/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Balance disorder	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Ataxia	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Decreased vibratory sense	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Dizziness	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Dystonia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Headache	13.6% 8/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	8.8% 5/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	10.5% 2/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	22.2% 2/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Lethargy	1.7% 1/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Myoclonus	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Parkinsonism	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Pineal gland cyst	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Nervous system disorders Syncope	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Psychiatric disorders Affect lability	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Psychiatric disorders Emotional poverty	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Psychiatric disorders Enuresis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Psychiatric disorders Irritability	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Psychiatric disorders Mood altered	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Psychiatric disorders Mood swings	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Renal and urinary disorders Pollakiuria	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Reproductive system and breast disorders Dysmenerrhoea	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Cough	16.9% 10/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	22.8% 13/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	31.6% 6/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	44.4% 4/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	27.3% 3/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.2% 6/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	7.0% 4/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	15.8% 3/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	18.2% 2/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Acanthosis	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 3/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	10.5% 2/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Erythema	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Granuloma skin	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Macule	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Pruritus	5.1% 3/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	17.5% 10/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	11.1% 1/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Vascular disorders Flushing	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	9.1% 1/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.
Vascular disorders Hypotension	0.00% 0/59 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/57 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	5.3% 1/19 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/9 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.	0.00% 0/11 • TEAEs were all the AEs reported up to the end of the Extension Treatment Period (Month 12). All AEs with an onset date on/after the start of the first infusion through 60 days after the last dose are included. A patient with more than one event with the same SOC is counted once Only AEs in the these arms/groups of interest were calculated: EryDex low dose and high dose, non-switch placebo, placebo patients who switched to EryDex (low dose or high dose) at 6 and 9 months, and patients remained on placebo till the end of the study. Please note that data collected on "placebo pre switch" group corresponds to data reported for placebo patients in the 6-Month Initial Treatment Period.

Additional Information

Irene Maccabruni, M.Sc.

Quince Therapeutics (former Erydel SpA)

Phone: +39 02 36504470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place