Table 1.
Clinical investigation endpoints: secondary endpoints
| Secondary endpoints | |
|---|---|
| Tolerability | |
| Injection discomfort | |
| Subject experience | 11-point scale from 0 = No Discomfort to 10 = Extreme Discomfort |
| Physician experience | 11-point scale from 0 = No Discomfort to 10 = Extreme Discomfort |
| Bruising in lips | |
| Subject experience | 5-point scale from None to Considerable |
| Physician experience | 5-point scale from None to Considerable |
| Swelling in lips | |
| Subject experience | 7-point scale from No Swelling to Swelling Not Resolved Yet (subjects without top-up treatment only) |
| Physician experience | 7-point scale from No Swelling to Swelling Not Resolved Yet |
| Injection characteristics | |
| Ease of use | |
| Physician experience | 11-point scale from 0 = Very Easy to 10 = Extremely Difficult |
| Malleability | |
| Physician experience | 11-point scale from 0 = Extremely Malleable to 10 = Not Malleable |
| Need for massage | |
| Physician experience | 4-point scale from None or Minimal to A Lot |
| Return to social engagement | |
| Subject experience | 5-point scale from <1 day to >6 days |
| Overall experience | |
| Physician experience | 4 questions |
| Subject experience | 2 questions (additional 2 questions for subjects without top-up treatment only) |
| Safety | |
| Subject experience | Evaluated by subject-reported adverse events and serious adverse events, directly related to the device, which occurred during the study and/or the follow-up period |
IQ1V: Injector Questionnaire – First Visit; IQEOS: Injector Questionnaire – End Of Study; IQFV: Injector Questionnaire – Follow-up Visit; SQ1V: Subject Questionnaire – First Visit; SQFV: Subject Questionnaire – Follow-up Visit.