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Table 1 Eligibility criteria

From: Efficacy of selenium supplementation for mild-to-moderate Graves’ ophthalmopathy in a selenium-sufficient area (SeGOSS trial): study protocol for a phase III, multicenter, open-label, randomized, controlled intervention trial

Inclusion criteria

Exclusion criteria

1. Age 19–75 years of either gender

2. Patients with mild-to-moderate GO with one of the following:

- Confirmation of mild-to-moderate GO by a professional ophthalmologist

- NO SPECS class 2a or 2b (mild or moderate involvement of soft tissue) [61]

- Proptosis of 22 mm or less

- No treatment for GO other than symptom control since diagnosis

3. Patients with Graves’ disease with normal thyroid function as indicated:

- Patients maintaining euthyroid status for at least 2 months with ATDs

- Patients with maintenance of euthyroid status from 6 months after RAI treatment

- If hypothyroidism occurred after Grave’ disease treatment including with ATDs, RAI, or surgery, patients who have euthyroid status under conditions of thyroid hormone replacement

- Patients who have been diagnosed with GO by an ophthalmologist but have not yet developed thyrotoxicosis and who are positive for anti-thyroid receptor antibodies

4. Patients who have voluntarily signed the written consent form

1. Patients with severe GO who meet at least one of the following criteria:

- NO SPECS class 2C (marked involvement of soft tissue)

- Proptosis greater than 22 mm

- Diplopia or ocular torticollis in a resting position

- Optic neuropathy

- Confirmation of severe GO by an ophthalmologist

2. Patients who have been treated with a high dose of steroids or any dose of selenium within 3 months:

- High-dose steroid treatment includes oral methylprednisolone more than 1 g per day or equivalent and intravenous steroids

3. Patients with contraindications for selenium supplementation meeting at least one of the following criteria:

- Hypersensitivity to selenium or a component of the pill

- Selenium toxicity

- Hereditary fructose intolerance, glucose-galactose malabsorption, or deficiency of sucrase or isomaltase

4. Patients with comorbidities or active disease under treatment

5. Pregnant or lactating women

  1. Inclusion and exclusion criteria for the SeGOSS study
  2. Abbreviations: GO Graves’ ophthalmopathy, ATD antithyroid drug, RAI radioactive iodine