Safety, Effectiveness and Participant Satisfaction Study of a Dermal Filler (of RADIESSE® (+) Lidocaine) in the Treatment of Ageing Signs in the Face

Time frame: Baseline up to Week 72 (for participants with no touch-up) or Week 76 (for participants with touch-up)

Population: The SES was the subset of all participants who were exposed to the SMD at least once. This OM was analyzed in all participants and by the subpopulations of each indication (participants treated for nasolabial folds, for marionette lines, and for cheek volume loss).

The MUCFS was used to assess the severity of volume loss of upper cheeks. The assessment was performed separately for the left and the right cheek by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MUCFS was a 5 point scale ranging as: 0 (full upper cheek), 1 (mildly sunken upper cheek), 2 (moderately sunken upper cheek), 3 (severely sunken upper cheek), 4 (very severely sunken upper cheek). Responders rate was defined as percentage of participants who achieved improvement of \>=1 point in both cheeks (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up.

Time frame: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed only for participants treated for cheek volume loss.

The MMLS was used to assess the severity of marionette lines. The assessment was performed separately for the left and the right marionette line by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MMLS was a 5 point scale ranging as: 0 (no lines), 1 (mild lines), 2 (moderate lines), 3 (severe lines), 4 (very severe lines). Responders rate was defined as percentage of participants who achieved improvement of \>=1 point in both marionette lines (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up.

Time frame: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed only for participants treated for marionette lines.

The MNLFS was used to assess the severity of nasolabial folds. The assessment was performed separately for the left and the right nasolabial fold by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MNLFS was a 5 point scale ranging as: 0 (no folds), 1 (mild folds), 2 (moderate folds), 3 (severe folds), 4 (very severe folds). Responders rate was defined as percentage of participants who achieved improvement of greater than or equal to (\>=) 1 point in both folds (left and right) from Day 1 pre-injection to Week 12/16 (depending on touch-up). As planned, the cumulative data was collected for Week 12 or Week 16 based on the touch-up.

Time frame: At Week 12 (for participants with no touch-up) or Week 16 (for participants with touch-up)

Population: The full analysis set (FAS) was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline Merz Aesthetics Scales (MAS) value of at least one treated indication was available. This outcome measure (OM) was analyzed only for participants treated for nasolabial folds.

The Subject's Global Aesthetic Improvement Scale (sGAIS) was used to assess aesthetic improvement in the participants by the participant by live rating using baseline photographs for comparison. The participant was asked: 'What is your overall impression of change of your aesthetic result due to treatment, compared to the condition before the injection? Please tick the one option that best fits your overall impression of change based on your comparison of the baseline visit photographs.' Rating based on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). As planned, the cumulative data was collected at Week 4 (prior to optional touch-up), Week 12 or 16, Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up.

Time frame: At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed in all participants and by the subpopulations of each indication. Here overall number of participants analyzed were participants who were evaluable for this outcome measure and number analyzed were participants who were evaluable for the outcome measure at given time points.

The Investigator's Global Aesthetic Improvement Scale (iGAIS) was used to assess aesthetic improvement in the participants by the treating investigator by live rating using baseline photographs for comparison. The treating investigator was asked: 'Based on your clinical experience, what is your overall impression of change of the participant's aesthetic result due to treatment, compared to the condition before the first treatment (baseline)? Please check the one option that best fits your overall impression of change based on your comparison of the baseline visit photographs.' Rating was based on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). As planned, the cumulative data was collected at Week 4 (prior to optional touch-up), Week 12 or 16, Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up.

Time frame: At Week 4 (prior to optional touch-up); at Weeks 12, 24, 48 and 72 (for participants with no touch-up) or at Weeks 16, 28, 52 and 76 (for participants with touch-up)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed in all participants and by the subpopulations of each indication. Here overall number of participants analyzed were participants who were evaluable for this outcome measure and number analyzed were participants who were evaluable for the outcome measure at given time points.

The MUCFS was used to assess the severity of volume loss of upper cheeks. The assessment was performed separately for the left and the right cheek by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MUCFS was based on 5 point scale ranging from: 0 (full upper cheek), 1 (mildly sunken upper cheek), 2 (moderately sunken upper cheek), 3 (severely sunken upper cheek), 4 (very severely sunken upper cheek). Responders rate was defined as percentage of participants who achieved improvement of \>=1 point in both cheeks (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up.

Time frame: At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed only for participants treated for cheek volume loss.

The MMLS was to be used to assess the severity of marionette lines. The assessment was performed separately for the left and the right marionette line by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MMLS was a 5 point scale ranging from: 0 (no lines), 1 (mild lines), 2 (moderate lines), 3 (severe lines), 4 (very severe lines). Responders rate was defined as percentage of participants who achieved improvement of \>=1 point in both marionette lines (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up.

Time frame: At Week 4 (prior to optional touch-up); and at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed only for participants treated for marionette lines.

The MNLFS was used to assess the severity of nasolabial folds. The assessment was performed separately for the left and the right nasolabial fold by the blinded rater and the treating investigator (at baseline only prior to SMD injection) by live rating. MNLFS was a 5 point scale ranging as: 0 (no folds), 1 (mild folds), 2 (moderate folds), 3 (severe folds), 4 (very severe folds). Responders rate was defined as percentage of participants who achieved improvement of \>=1 point in both folds (left and right) from Day 1 pre-injection to Week 4, Week 24/28, Week 48/52, and Week 72/76 (depending on touch-up). As planned, the cumulative data was collected for Week 24 or 28, Week 48 or 52, and Week 72 or 76 based on the touch-up.

Time frame: At Week 4 (prior to optional touch-up); at Weeks 24, 48 and 72 (for participants with no touch-up) or at Weeks 28, 52 and 76 (for participants with touch-up)

Population: The FAS was the subset of all participants who were exposed to the SMD at least once and for whom a baseline and a post-baseline MAS value of at least one treated indication was available. This OM was analyzed only for participants treated for nasolabial folds.