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. 2015 May 26;21:1512–1519. doi: 10.12659/MSM.894119

Table 2.

Study procedures and assessments.

Screening Induction TPE Maintenance TPE
Day/month 0 1D 2D 3D 4D 5D 1M 2M 3M 4M
Informed consent x
In/Exclusion criteria x
Physical examination* x x x x x x x x x x
Neurological examination** x x x x x x
IFN-β BAbs*** x x x x
Lab values# x x x x
IFN-β bioavailability## x x x x x x
TPE x x x x x x x
(S)AEs assessment and reporting x Whenever (serious) adverse events occurs
*

ABP, HR, Resp, body temperature, ECG;

**

Neurological examination, EDSS;

***

BAbs measured with ELISA before MxA expression;

#

Hb, WBC, PLT, electrolytes, TP, coagulation (APTT, PA, fibrinogen);

##

MxA mRNA expression (before IFN-β injection and 12 hours after injection). INF-β – interferon beta; BAbs – binding antibodies; MxA – myxovirus resistance protein A; mRNA – messenger RNA; TPE – therapeutic plasma exchange.