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Fabulinus screening

Please take a few minutes of your time to complete the following questionnaire.

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Inclusion/Exclusion Criteria
1

How old are you?

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2

Have you initiated exogenous insulin therapy?

Select one answer
3

If so, when did you initiate insulin?

Select a date
4

What type of insulin replacement therapy are you currently taking?

Select one or more answers
5

Which of the following T1D antibodies are you positive for?

Select one or more answers
6

Have you had your random c-peptide level tested? If so what was the level (if you know)?

7

Are you up to date on your vaccines?

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Inclusion/Exclusion Criteria
8

In the last 30 days, have you had a serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus (CMV), Epstein-Barr Virus (EBV) as determined at screening), bacterial, or fungal infection (eg, osteomyelitis)?

Select one answer
9

Do you have a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution?

Select one answer
10

Do you have active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing?

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11

Do you have evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection, medical or surgical condition (eg, but not limited to, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, acquired or inherited bone/skeletal disorders including repeated bone fractures for unknown reason, juvenile osteoporosis, osteogenesis imperfecta, osteochondropathies, or any known immune deficiency), or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation)?

Select one answer
12

Do you have history or current hypogammaglobulinemia?

Select one answer
13

Do you have history of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb? Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)

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14

Do you have any other autoimmune diseases (eg, rheumatoid arthritis [RA], polyarticular juvenile idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], MS, SLE), except autoimmune thyroiditis with controlled function of thyroid gland and celiac disease (at discretion of investigator)?

Select one answer
15

Do you have history, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, antiphospholipid syndrome, other prothrombotic disorders (eg, congenital or inherited deficiency of antithrombin III, protein C, protein S, and Factor V Leiden mutations) and/or participants requiring antithrombotic treatment?

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16

Do you have diabetes of forms other than autoimmune T1D that include but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), secondary to medications or surgery, type 2 diabetes by judgement of the investigator?

Select one answer
17

Do you have a history of malignancy of any organ system, treated or untreated, within the last 5 years, regardless of whether there is evidence of local recurrence or metastases?

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Inclusion/Exclusion Criteria
18

Have you taken systemic corticosteroids (duration >7 days), adrenocorticotropic hormone in the last month?

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19

Have you had any IV, IM or SC administered biologic treatments, <3 months or <than 5 half-lives (whichever is longer), prior to randomization?

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20

Have you had any live (attenuated or viral-vector) vaccine (including but not limited to varicella zoster, oral polio, nasal influenza, rabies) within the last 3 months?

Select one answer
21

Have you had any immunosuppressive therapy within the last 12 weeks?

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22

Have you ever had a course of Thymoglobulin®, teplizumab or other immunomodulatory?

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23

Are you currently taking any glucagon-like peptide 1 (GLP-1) agonists, sodium–glucose co-transporter-2 and 1 (SGLT2/1) inhibitor, and verapamil?

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24

Have you taken other investigational drug within 100 days or 5 half-lives?

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25

Have you ever received Frexalimab (the investigational product) before?

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