Fig. 2.

Visit schedule and assessment

Fig. 2 highlights the visit schedule for all patients including the screening period, treatment period and follow-up visit. Footnotes are the following:

* visits 1, 3, 5 and 7 are required for part I- group, for part II-group the necessity for these visits will be determined by results from part I-group and advises of the DMC.

¹ only at baseline inclusive height

² CD4, CD8, B and NK cell numbers

³ 125 mg/ml syringe weekly; sc injection at clinic and dispensing of investigational product for administration at home (once weekly)

⁴ administration of first dose of trial medication and subsequent observation for at least 30 min after administration

⁵ re-education, if needed

⁶ dispensing of patient diary and education on completion

⁷ special tubes for mRNA collection

⁸ documentation period AE/reporting period SAE from 1st application of IMP until 30 days after last application of IMP

⁹before 1st application of IMP just documentation and reporting of SAE ¹⁰ last sc injection at clinic; NO dispensing of investigational product for administration at home (once weekly).