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Study Enrollment and Randomization Process for Clinical Trial: CONSORT Diagram Analysis

This supplementary figure presents the clinical trial protocol schematically, outlining the screening for eligibility among 19 participants. A total of 5 participants were excluded based on not meeting inclusion criteria, while 14 were enrolled and subsequently randomized into two arms. In Arm 1 (n=7), two participants were removed prior to vaccination due to disease progression and the development of dermatomyositis. In Arm 2 (n=7), one participant was removed due to an active lung infection. The outcomes following vaccination are also detailed, highlighting recurrence rates in both arms.

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Study Enrollment and Randomization Process for Clinical Trial: CONSORT Diagram Analysis

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  1. Suppl Fig. 1a The clinical protocol is shown schematically.

  2. Screened for eligibility (n=19) Excluded (n=5) Not meeting inclusion criteria (n=5)  Declined to participate (n=0) Died prior to enrolment (n=0) Enrolled (n=14) Randomized to Arm 1(n=7) Removed from study prior to vaccination (n=2) - Disease progression during vaccine production (n=1) - Developed dermatomyositis (n=1) Randomized to Arm 2(n=7) Removed from study prior to vaccination (n=1) - Developed active lung infection (n=1) Received any vaccines (n=5) Recurred after 2 vaccinations (n=1) Received any vaccines (n=6) Recurred after 1 vaccination (n=1) • Included in analysis (n=5) • Included in analysis (n=5) Suppl Fig. 1b The CONSORT diagram of the study enrollment.

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