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Table 1 Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE) inclusion criteria

From: Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial

1.

Between 15 and 45 years of age, inclusive, at Visit 1

2.

Antinuclear antibody titer of 1:80 or greater at Visit 1, as determined by immunofluorescence assay in the Oklahoma Medical Research Foundation laboratory

3.

Participants must have at least one (but not three or more) additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics classification criteria

4.

Written informed consent (and assent when applicable) obtained from subject or subject’s legal representative and ability for subject to comply with the requirements of the study, including willingness to take hydroxychloroquine