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Safety and tolerability data indicate that BAN2401 is well-tolerated at single doses up to 15 mg/kg intravenously and at multiple doses of up to 10 mg/kg intravenously biweekly.
Dasatinib appears to be generally well tolerated, regardless of disease phase, and long-term tolerability data are eagerly awaited.
Sensitivity analyses were conducted using alternative efficacy and tolerability data.
Safety and tolerability data of repeated use of UPA EC were also collected.
The 150-mg dose of armodafinil was selected based on efficacy and tolerability data from previous clinical trials.
Long-term efficacy and tolerability data are not yet available for patch formulations of dopamine agonists in restless legs syndrome.
This approach appears to have come from complex considerations regarding cost, ease of administration, and availability of long-term efficacy and tolerability data.
These factors make the comparison of efficiency and tolerability data difficult and pose challenges when trying to standardize this method of treatment and decide best practice.
The investigator collected safety and tolerability data by asking participants to provide subjective responses at each study visit regarding any AEs after nVNS use.
All efficacy, healthcare resource utilisation, onabotulinumtoxinA utilisation, safety, and tolerability data are assessed at baseline and each follow-up visit as described below.
"Although we expect ultimate approval, a delay would not be surprising given tolerability data and questions on minimally effective dosing of the drug," she added.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com