Trial Outcomes & Findings for A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) (NCT NCT00444626)

Last Updated: 2015-04-22

Results Overview

This was a comparison of the mean change between Baseline and the Week 24 score (baseline minus week 24 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement. Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

140 participants

Primary outcome timeframe

Week 24

Results posted on

2015-04-22

Participant Flow

166 subjects screened, 26 subjects were never randomized.

Participant milestones

Participant milestones
Measure	Combined Arm Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
Initial Treatment Period STARTED	140
Initial Treatment Period COMPLETED	128
Initial Treatment Period NOT COMPLETED	12
Repeat Treatment Period STARTED	105
Repeat Treatment Period COMPLETED	105
Repeat Treatment Period NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Combined Arm Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
Initial Treatment Period Withdrawal by Subject	2
Initial Treatment Period Adverse Event	1
Initial Treatment Period Lost to Follow-up	9

Baseline Characteristics

A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Arms n=140 Participants Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
Age, Continuous	52.7 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	9 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	24 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 participants n=5 Participants
Race/Ethnicity, Customized White	100 participants n=5 Participants
Race/Ethnicity, Customized Other	5 participants n=5 Participants
Race/Ethnicity, Customized Not Available	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Full Analysis Set (FAS) population includes all randomized participants who received both study treatments and had some post-treatment effectiveness data. For the effectiveness analyses based on the FAS population, participants were analyzed as randomized. The FAS population was identical to an intent-to-treat population.

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=129 nasolabial folds Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=129 nasolabial folds Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF Adverse events that did not occur at the nasolabial folds
Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24	1.8 Units on a scale Standard Deviation 1.0	1.8 Units on a scale Standard Deviation 1.1	—

SECONDARY outcome

Timeframe: Day 1

The pain experienced by each participant at the time of injection (time 0) and at 15 and 30 minutes after injection during the initial treatment visit was evaluated. Pain was measured using a VAS of 0 mm (no pain) to 100 mm (extreme pain).

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=129 Participants Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=129 Participants Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF Adverse events that did not occur at the nasolabial folds
Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) 0 time after injection	23.2 Units on a scale Standard Deviation 20.3	48.9 Units on a scale Standard Deviation 26.0	—
Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) 30 minutes after injection	3.3 Units on a scale Standard Deviation 7.0	7.9 Units on a scale Standard Deviation 13.0	—
Participant's Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS) 15 minutes after injection	6.1 Units on a scale Standard Deviation 10.1	16.3 Units on a scale Standard Deviation 18.0	—

SECONDARY outcome

Timeframe: Week 36

Mean change between Baseline and the Week 36 score (Baseline minus week 36 scores) in the blinded evaluators' assessments of NLF wrinkle severity. A positive value for the mean change indicates an improvement. Genzyme 6-Point Grading Scale (GGS) for NLF was used for the assessment. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=127 nasolabial folds Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=127 nasolabial folds Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF Adverse events that did not occur at the nasolabial folds
Change From Baseline in the Blinded Evaluator's Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36	1.3 Units on a scale Standard Deviation 1.2	1.3 Units on a scale Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: Week 24

Count of participants with at least a 1-point improvement from Baseline in the Genzyme 6-Point Grading Scale (GGS) at Week 24. A GGS score of zero indicates no wrinkles and a score of 5 indicates very deep wrinkles with redundant folds.

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=129 Participants Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=129 Participants Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF Adverse events that did not occur at the nasolabial folds
Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator's Assessment of Wrinkle Severity at Week 24	114 Participants	113 Participants	—

SECONDARY outcome

Timeframe: Week 24

Participants indicated their product preference at Week 24 after Date of Optimal Correction (DOC).

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=129 Participants Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=129 Participants Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF Adverse events that did not occur at the nasolabial folds
Participant Product Preference at Week 24	56 Participants	68 Participants	—

SECONDARY outcome

Timeframe: Week 36

Participants indicated their product preference at Week 36 after Date of Optimal Correction (DOC).

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=129 Participants Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=129 Participants Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF Adverse events that did not occur at the nasolabial folds
Participant Product Preference at Week 36	62 Participants	55 Participants	—

SECONDARY outcome

Timeframe: Weeks 1-36

Population: Number of patients randomized to initial treatment phase. Safety Population.

Counts of participants with treatment-emergent adverse events (AEs) from the time of injection up to Week 36. AEs are presented regardless of relationship to study device and/or procedure. If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as the most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive.

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=140 Participants Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=140 Participants Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF n=140 Participants Adverse events that did not occur at the nasolabial folds
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Relationship - Device Related	91 Participants	78 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period Patients with at least one Adverse Event (AE)	99 Participants	89 Participants	28 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Severity - Mild	47 Participants	58 Participants	13 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Severity - Moderate	37 Participants	24 Participants	10 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Severity - Severe	15 Participants	7 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Relationship - Procedure or Device	98 Participants	87 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Relationship - Procedure Related	69 Participants	61 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Duration - less than or equal to 7 days	70 Participants	67 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Duration - more than 7 days	29 Participants	22 Participants	23 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Treatment - No Treatment	54 Participants	57 Participants	6 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Treatment - Medication	13 Participants	8 Participants	18 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Treatment - Non-drug Therapy	32 Participants	24 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period AEs by Treatment - Hospitalization	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period Patients with Baseline AEs	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period Patients with Serious AEs	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period Patients with Study Discontinuation due to AEs	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period Number of Deaths	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: weeks 36 up to 47 weeks

Population: Safety Population for repeat treatment.

Count of participants with treatment-emergent adverse events (AEs) from the time of injection for the repeat treatment period up to week 47. AEs are presented regardless of relationship to study device and/or procedure. If a participant had more than one occurrence of the same AE, he/she was counted only once. The most severe occurrence of an AE, as well as most extreme relationship of the AE to the device, was indicated in cases of multiple occurrences of the same AE. For AEs by relationship, procedure-related and device-related AEs are not mutually exclusive and therefore are not additive.

Outcome measures

Outcome measures
Measure	Dermal Gel Extra (DGE) n=105 Participants Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.	Restylane n=105 Participants Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.	Non-NLF n=105 Participants Adverse events that did not occur at the nasolabial folds
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Severity - Mild	32 Participants	34 Participants	5 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Relationship - Procedure or Device (DGE)	54 Participants	50 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Relationship - Procedure Related	50 Participants	46 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period Patients with a Serious AEs	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Treatment - Non-drug Therapy	7 Participants	7 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Treatment - Hospitalization	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period Patients with at least one Adverse Event (AE)	55 Participants	52 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Severity - Moderate	19 Participants	15 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Severity - Severe	4 Participants	3 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Relationship - Device (DGE) Related	51 Participants	47 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Duration - less than or equal to 7 days	44 Participants	44 Participants	7 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Duration - more than 7 days	11 Participants	8 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Treatment - No Treatment	41 Participants	40 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period AEs by Treatment - Medication	7 Participants	5 Participants	6 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period Patients with Study Discontinuation due to AEs	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period Number of Deaths	0 Participants	0 Participants	0 Participants

Adverse Events

Dermal Gel Extra (DGE): Initial Treatment Period

Serious events: 0 serious events

Other events: 99 other events

Deaths: 0 deaths

Restylane: Initial Treatment Period

Serious events: 0 serious events

Other events: 89 other events

Deaths: 0 deaths

Non-NLF: Initial Treatment Period

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Dermal Gel Extra (DGE) - Repeat Treatment Period

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Non-NLF: Repeat Treatment Period

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dermal Gel Extra (DGE): Initial Treatment Period n=140 participants at risk Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment.	Restylane: Initial Treatment Period n=140 participants at risk Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment.	Non-NLF: Initial Treatment Period n=140 participants at risk Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment.	Dermal Gel Extra (DGE) - Repeat Treatment Period n=105 participants at risk Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.	Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period n=105 participants at risk Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.	Non-NLF: Repeat Treatment Period n=105 participants at risk Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Gastric ulcer	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.

Other adverse events

Other adverse events
Measure	Dermal Gel Extra (DGE): Initial Treatment Period n=140 participants at risk Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment.	Restylane: Initial Treatment Period n=140 participants at risk Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment.	Non-NLF: Initial Treatment Period n=140 participants at risk Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment.	Dermal Gel Extra (DGE) - Repeat Treatment Period n=105 participants at risk Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.	Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period n=105 participants at risk Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.	Non-NLF: Repeat Treatment Period n=105 participants at risk Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Reproductive system and breast disorders Menorrhagia	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site swelling	55.7% 78/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	49.3% 69/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	44.8% 47/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	44.8% 47/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site pain	43.6% 61/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	40.7% 57/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	32.4% 34/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	30.5% 32/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site bruising	25.0% 35/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	20.7% 29/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	21.9% 23/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	21.9% 23/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site erythema	21.4% 30/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	19.3% 27/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	31.4% 33/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	31.4% 33/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site nodule	8.6% 12/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	4.3% 6/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	2.9% 3/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site pruritus	7.9% 11/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	5.7% 8/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	5.7% 6/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	6.7% 7/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site anaesthesia	4.3% 6/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site induration	1.4% 2/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site paraesthesia	1.4% 2/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site discolouration	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site discomfort	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site dryness	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site haemorrhage	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site inflammation	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Injection site papule	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Cyst	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Influenza like illness	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
General disorders Pyrexia	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Nasopharyngitis	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	2.9% 4/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Upper respiratory tract infection	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	2.1% 3/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	1.9% 2/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Bronchitis	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Gastroenteritis viral	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Herpes zoster	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Onychomycosis	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Pneumonia	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Viral infection	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Injection site pustule	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Infections and infestations Sinusitis	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Contusion	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Fall	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Open wound	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Post procedural diarrhoea	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Post procedural swelling	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Postoperative constipation	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	1.4% 2/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Musculoskeletal and connective tissue disorders Resorption bone increased	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Localised intraabdominal fluid collection	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Oral disorder	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Stomach discomfort	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Vomiting	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Duodenitis	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Gastritis	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Lip swelling	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Nervous system disorders Headache	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	2.1% 3/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Nervous system disorders Dizziness	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Nervous system disorders Sinus headache	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Immune system disorders Allergy to arthropod bite	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Immune system disorders Seasonal allergy	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Investigations Bone density decreased	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Investigations Intraocular pressure increased	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Skin and subcutaneous tissue disorders Blister	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Eye disorders Vitreous floaters	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.71% 1/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/140 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.00% 0/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.	0.95% 1/105 • Initial Treatment Period (week 1 to week 36) and Repeat Treatment Period (week 36 up to week 47) Participant counts of AEs are broken out by Initial Treatment Period and Repeat Treatment Period. Then further summarized as AEs occurring at the nasolabial fold initially treated with DGE, the nasolabial fold initially treated with Restylane, and AEs that did not occur at the nasolabial folds.

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