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. 2018 Oct 9;12:3377–3392. doi: 10.2147/DDDT.S178456

Table 6.

Observed treatment-emergent AEs

AEs Mild grade
Causality assessment Taken action/outcome
Reference Test

Nausea 3 (9.7%) 2 (6.5%) Possibly related None/recovered
Headache 1 (3.2%) 1 (3.2%) Possibly related None/recovered
Dizziness 1 (3.2%) 0 Possibly related None/recovered
Vasovagal reflex 1 (3.2%) 0 Unclassifiable Bed rest/recovered

Notes: The severity grade of all observed AEs was mild. No serious AEs (moderate to severe grade) were observed.

Abbreviation: AEs, adverse events.