SARO.23.002
6 evidence topics · 2 sources
Objective
Extension objective
Location and study date
No evidence found.
Study design
Open-label extension design
Eligibility criteria
Eligibility after the parent trial
Treatment
Study outcomes
Rationale for using safety during extended treatment as the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Registry-reported enrollment
| Population | Participants |
|---|---|
| Open-label extension | “102” |
Description of analysis sets
No evidence found.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
No evidence found.
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
No evidence found.
Study limitations
Summary
Eligibility requires completion of the parent double-blind trial. This selects participants able to complete earlier treatment and does not recreate a randomized untreated comparator. The registry reports 102 participants, but the report contains no extension results.