Study Drugs Administered Sample Clauses

Study Drugs Administered. After successfully meeting entry criteria, during the screening and baseline visits, eligible patients will be randomly assigned to the IPP-201101 treatment group or to the placebo treatment group (see section 3.3). Study drug will be packaged in single-dose vials; the study center with receive box(es) with up to 13 vials per box. Each vial will be labeled with a 4-digit treatment number and each box will contain a mix of IPP-201101 or placebo vials (see section 3.4). Study drug exposure will be measured, and study drug will be administered sc by qualified study personnel at visit 2 and visits 4 through 15. Study drug may not be administered by the same individual performing the SLEDAI-2K, BILAG-2004, or PhGA. Study drug should be administered at each study visit after all study visit procedures and assessments have been completed. The pharmacy manual provided by ImmuPharma includes details on storage, administration, reconstitution, syringe information, and preparation of the study drug.
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