Evaluation of the Effectiveness and Safety of the Ulthera® DeepSEE® System for Treating Skin Laxity in the Lower Face and Submentum
Phase: NA
Conditions: Improvement in Skin Laxity of the Lower Face and Submentum
Sponsor: Merz North America, Inc.



Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page iii of iii 
Select exclusion criteria are as follows: 
• 
Scarring in area(s) to be treated; 
• 
Any active implants (e.g., pacemakers or defibrillators) in the area(s) 
to be treated; 
• 
Any metallic implants in area(s) to be treated; 
• 
Any open wounds or lesions in the area(s) to be treated; 
• 
Body mass index (BMI) less than 19 or greater than 30; or 
• 
Gain or loss of ≥ 2 BMI units within the previous 90 days or has the 
intention to gain or lose ≥ 2 BMI units during the course of the trial. 
 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 6 of 93 
3 TABLE OF CONTENTS 
1
TITLE PAGE .............................................................................................. 1
2
SYNOPSIS ................................................................................................... i
3
TABLE OF CONTENTS............................................................................ 6
4
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .......... 10
5
ETHICS .................................................................................................... 16
 
Ethical Conduct of the Trial ................................................................... 16
 
Informed Consent................................................................................... 16
 
Subject Privacy ...................................................................................... 17
 
Confidentiality of Subject Information ................................................... 17
 
Insurance ............................................................................................... 18
 
Financing............................................................................................... 18
6
INTRODUCTION .................................................................................... 19
Background ............................................................................................ 19
 
Trial Rationale ....................................................................................... 20
6.2.1
Justification of Proposed Trial Design and Primary Effectiveness 
Endpoint........................................................................................... 20
 
Potential Benefits and Risks ................................................................... 20
7
TRIAL OBJECTIVES AND ENDPOINTS ............................................. 22
 
Objective ............................................................................................... 22
 
Endpoints ............................................................................................... 22
7.2.1
Effectiveness Endpoints ................................................................... 22
7.2.1.1 
Primary Effectiveness Endpoint .................................................. 22
7.2.1.2
Secondary Effectiveness Endpoints............................................. 22
7.2.2
Safety Endpoints .............................................................................. 26
7.2.2.1 
Secondary Safety Endpoint ......................................................... 26
8
CLINICAL INVESTIGATION PLAN .................................................... 27
 
Overview of Trial Design ....................................................................... 27
 
Discussion of Trial Design, Including the Choice of Control Groups ...... 28
9
TRIAL POPULATION AND RESTRICTIONS ..................................... 29
 
Number of Subjects and Sites ................................................................. 29
Selection of Subject Population.............................................................. 29
9.2.1
Inclusion Criteria .............................................................................. 29
9.2.2
Exclusion Criteria............................................................................. 30
9.2.4
Subject Enrollment and Randomization ............................................ 33
9.2.5
Screen Failures ................................................................................. 33

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 7 of 93 
9.2.6
Removal of Subjects from Therapy or Assessment ........................... 33
9.2.6.1 
Treatment Discontinuation ......................................................... 33
9.2.6.2 
Subject Withdrawal or Discontinuation ...................................... 33
9.2.6.3 
Provision of Care for Subjects after Trial Discontinuation ......... 34
9.2.7
Suspension or Premature Termination of an Investigative Site.......... 35
9.2.8
Suspension or Premature Termination of the Trial ............................ 35
9.2.9
End of Trial ...................................................................................... 36
10
TRIAL DEVICE AND TREATMENT OF SUBJECTS ......................... 37
 
Description of Trial Device .................................................................... 37
 
Methods of Assigning Subjects to Trial Groups...................................... 39
 
Blinding Procedures ............................................................................... 40
10.4.1
Blinding ........................................................................................... 40
10.4.2
Planned Unblinding .......................................................................... 40
 
Trial Treatment ...................................................................................... 40
10.5.1
Planned Treatment Procedure and Administration ............................ 40
10.5.1.1 
Pre-treatment Assessments ......................................................... 40
10.5.1.3 
Treatment Regions and Treatment Administration Procedure ..... 41
10.5.2
Selection and Timing of Treatment for Each Subject ........................ 44
10.5.3
Treatment Interruption and Modification .......................................... 44
 
Prior and Concomitant Therapy .............................................................. 44
 
Trial Supplies and Packaging of Treatment Supplies .............................. 44
Receipt, Storage, Dispensing, and Return............................................... 45
 
Device Accountability Procedures .......................................................... 45
 Treatment Compliance ........................................................................... 46
 Duration of Trial .................................................................................... 46
11
TRIAL PROCEDURES ........................................................................... 47
 
Visit Schedule ........................................................................................ 47
11.1.1
Scheduled Visits ............................................................................... 48
11.1.2
Unscheduled Visits ........................................................................... 48
 
Trial Assessments and Definitions.......................................................... 48
11.2.1
Effectiveness Assessments ............................................................... 48
11.2.1.4 
FACE-Q Assessment ................................................................... 51
11.2.1.5 
Subject Global Aesthetic Improvement Scale (sGAIS) ................. 52
11.2.1.6 
Treating Investigator Global Aesthetic Improvement Scale (iGAIS)
................................................................................................... 52
11.2.2
Safety Assessments .......................................................................... 52
11.2.2.1 
Adverse Events (AEs) / Serious Adverse Events (SAEs) ............... 52
11.2.3
Additional Data Collected ................................................................ 55

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 8 of 93 
11.2.3.2 
Vital Signs .................................................................................. 55
11.2.4
Appropriateness of Assessments....................................................... 55
12
SAFETY DEFINITIONS AND REPORTING REQUIREMENTS ....... 56
Definition of an Adverse Event (AE) ..................................................... 56
12.1.1
Details of an AE ............................................................................... 56
12.1.2
Reporting and Handling of an AE ..................................................... 56
12.1.3
Severity Grading for an AE .............................................................. 57
12.1.4
Causal Relationship of an AE with an Investigational Medical Device
......................................................................................................... 57
12.1.5
Outcome Categories for an AE ......................................................... 58
 
Definition of a Serious Adverse Event (SAE) ......................................... 58
12.2.1
Details of an SAE ............................................................................. 59
12.2.2
Reporting and Handling of an SAE .................................................. 59
Definition of an Adverse Device Effect (ADE) ...................................... 61
 
Definition of a Serious Adverse Device Effect (SADE) .......................... 61
12.4.1
Definition of an Anticipated Serious Adverse Device Effect (ASADE)
......................................................................................................... 61
12.4.2
Definition of an Unanticipated Serious Adverse Device Effect 
(USADE) ......................................................................................... 61
 
Reporting of Pregnancy .......................................................................... 61
 
Definition of Device Deficiency ............................................................. 62
12.7.1
Reporting and Handling of Device Deficiencies ............................... 62
13
STATISTICAL METHODS..................................................................... 64
 
Randomization ....................................................................................... 64
 
Populations for Analysis ........................................................................ 64
 
Analysis of Trial Data ............................................................................ 65
13.4.1
Effectiveness Analyses ..................................................................... 65
13.4.1.1 
Primary Effectiveness Endpoint .................................................. 65
13.4.1.2 
Secondary Effectiveness Endpoints............................................. 66
13.4.2
Safety Analyses ................................................................................ 67
13.4.2.1
Secondary Safety Endpoints........................................................ 67
 
Special Statistical/Analytical Issues ....................................................... 69
13.5.2
Interim Analyses .............................................................................. 70
13.5.3
Multiple Comparisons/Multiplicity ................................................... 70
14
ADMINISTRATIVE PROCEDURES ..................................................... 71
 
Trial Monitoring .................................................................................... 71
Data Quality Assurance and Standardization Procedures........................ 71

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 9 of 93 
 
Source Documentation Requirements..................................................... 71
14.3.1
Data Management ............................................................................ 72
14.3.2
Data Review and Clarification Procedures ........................................ 72
14.3.3
Direct Access to Source Data/Documents ......................................... 73
14.3.4
Auditing ........................................................................................... 73
 
Protocol Deviations and Amendments .................................................... 74
14.4.1
Protocol Deviations .......................................................................... 74
14.4.2
Protocol Amendments ...................................................................... 74
 
Record Retention ................................................................................... 75
 
Clinical Trial Report .............................................................................. 76
 
Publication of Trial Results .................................................................... 76
 
Financial Disclosure ............................................................................... 76
 
Investigator Compliance ........................................................................ 76
15
REFERENCE LIST.................................................................................. 77
16
APPENDICES .......................................................................................... 79

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 14 of 93 
Responsibilities of All Parties 
Sponsor’s Statement 
The sponsor should perform duties according to Article 6 of “State Food and Drug 
Administration National Health and Family Planning Commission” (No. 25, People’s 
Republic of China, National Health and Family Planning Commission, National Medical 
Products Administration). The clinical trial institution and the investigators should perform 
duties according to Article 7 of “State Food and Drug Administration, National Health and 
Family Planning Commission” (No. 25, People’s Republic of China, National Health and 
Family Planning Commission, National Medical Products Administration). 
Investigator’s Statement 
I agree that: 
1. I will conduct this clinical trial in strict compliance with the Declaration of Helsinki, 
current laws and regulations of China, and the requirements of the protocol. 
2. I will record all required data accurately and in a timely manner on the Case Report 
Form (CRF) and complete the final report of the clinical trial on time. 
3. The investigational medical devices will be used only for this clinical trial, and the 
receipt and use of the investigational medical devices will be recorded completely and 
accurately, and the records will be retained during the process of the clinical trial. 
4. The monitor and verifier, as authorized or designated by the sponsor, and the regulatory 
authorities are allowed to conduct monitoring, verification, and inspection for the 
clinical trial. 
5. The clinical trial should be conducted in strict compliance with contract/articles of 
agreement signed by all parties. 
I have already read the clinical trial protocol, including the above statement, and I fully 
agree to all the above requirements. 
 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 15 of 93 
Comments from the sponsor: 
Signature (stamp): 
Date (MM/DD/YYYY): 
 
Comments from the investigator: 
Signature (stamp): 
Date (MM/DD/YYYY): 
 
Comments from the medical device clinical trial institution: 
Signature (stamp): 
Date (MM/DD/YYYY): 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 16 of 93 
5 ETHICS 
 
Ethical Conduct of the Trial
This trial will be performed in accordance with the principles outlined in the Declaration 
of Helsinki and in compliance with the standards for Good Clinical Practice (GCP) 
described in International Organization for Standardization as adopted by the European 
Union (EN ISO) 14155 and in China’s GCP for Medical Devices (Chinese GCP; No. 25 
Order of China National Medical Products Administration (NMPA) and National Health 
and Family Planning Commission of the People’s Republic of China (NHFPC)), Notice on 
Issue of Guidelines for the Design of Medical Device Clinical Trials (CFDA 2018 No. 6), 
and any applicable regional or national laws and regulations. The trial will adhere to all 
applicable subject privacy requirements. Regulatory authorities will be notified and 
consulted as required prior to, during, and after the conduct of the trial. 
All required approvals, favorable opinions, or additional requirements of the appropriate 
Independent Ethics Committee (IEC), Institutional Review Board (IRB), or other 
regulatory authority will be obtained prior to initiation of the trial. 
The investigator and all trial personnel will conduct the trial in compliance with this 
protocol. The investigator will ensure that all personnel involved in the conduct of this trial 
are qualified to perform the assigned trial responsibilities. Investigators will adhere to all 
applicable trial-reporting requirements. 
 
Informed Consent 
A subject will provide verbal and written informed consent to the investigator (or 
authorized designee) according to the provisions set forth in the Declaration of Helsinki, 
EN ISO 14155 (Chapter 4.7), and Chinese GCP. The obligations of the investigator are set 
forth in the clinical trial protocol (CTP), the Declaration of Helsinki, EN ISO 14155, 
Chinese GCP, and local Chinese requirements governing medical research and 
experimentation on humans. Consent must be obtained from every subject prior to the 
initiation of any screening or trial procedures. The informed consent process must be 
traceable from the available documentation. At a minimum, this documentation should 
include information about when the subject was first informed about the investigation and 
who supplied the information. 
If the informed consent form (ICF) is amended during the trial, the investigator and the 
contract research organization (CRO) must follow all applicable regulatory requirements 
pertaining to approval of the amended ICF by the IEC/IRB and use of the amended form. 
Ongoing subjects will be required to re-confirm consent by signing the amended form. 
One original, and any amended, signed and dated ICF(s) must be retained at the 
investigative site; a second original signed and dated ICF(s) must be given to the subject. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 17 of 93 
During the trial, the subject will be informed if information becomes available that may be 
relevant to the subject’s willingness to continue participation in the trial. In the case of an 
adverse event (AE) or poor tolerability to the trial device(s), the subject should inform the 
investigator, who will then make a judgment whether continuing in the investigation serves 
the subject’s best interest. The subject, however, is free to withdraw consent at any time 
and for any reason, whether expressed or not. 
 
Subject Privacy 
The subject will be informed of procedures to protect subject privacy. The CRO, the 
sponsor, or an authorized vendor will process subject data only in accordance with the 
data-protection provisions set forth in the German Federal Data Protection Act 
(Bundesdatenschutzgesetz), specifically in the version applicable as of 25-MAY-2018, and 
in Regulation (European Union or EU) 2016/679 (General Data Protection Regulation). 
Informed consent on data processing will be obtained in writing directly from the subject 
before recording of any data. Authorization to use and disclose health information that 
could identify the subject (referred to as protected health information or PHI) will be 
obtained in writing directly from the subject before recording of any data. Recorded data 
will be pseudonymized before transferring to authorized individuals. The investigator will 
maintain source documents that link unique subject numbers with subject names (e.g., in 
case of emergencies). 
 
Confidentiality of Subject Information 
Subject pseudo-anonymity is to be maintained during the trial. Subjects will be identified 
by a unique, assigned number on all trial documentation. Health information that could 
identify the subject (i.e., PHI) must be maintained in strict confidence by the investigator, 
to the extent permitted by applicable laws and regulations. Subjects must allow PHI to be 
disclosed to the sponsor and anyone working on behalf of the sponsor, the IRB/IEC, or 
regulatory authorities. 
Confidentiality will also be maintained for any medical information obtained from the 
subject during trial participation. At a subject’s request, the subject’s medical information 
may be provided to the other appropriate medical personnel. 
If the results of the investigation are published, the subject’s identity will remain 
confidential. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 18 of 93 
 
Insurance 
The trial sponsor will provide insurance. From the beginning of the investigation until its 
termination, each subject is insured against any health impairment occurring as a result of 
participation in the investigation in accordance with Chinese laws and regulations. 
The subject will be informed by the investigator and through the ICF about the existence 
of this insurance and the resulting obligations. The insurance conditions will be distributed
to the subject if requested or if required by local Chinese requirements. 
Any medical deviation from the CTP that is deemed to have occurred through the subject’s 
own fault is not covered by this insurance. 
Relatedness of potential injury to trial devices and/or procedures should be assessed by the 
treating investigator. The sponsor is usually not liable for injuries or deaths that occur 
solely because of the subject’s pre-existing medical condition(s) or from diagnostic or 
therapeutic measures not specifically required by the agreed CTP. The sponsor is also 
usually not liable for events resulting from negligence of the investigator, trial personnel, 
and/or CRO, including failure to act according to EN ISO 14155 principles and/or 
Chinese GCP or to comply strictly with the agreed CTP. 
The terms of the insurance will be kept in the trial files. 
 
Financing 
The financial aspects of the investigation will be documented in an agreement between the 
sponsor, the CRO, and each investigator or any other involved party, and must be 
confirmed in writing before the investigation commences. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 19 of 93 
6 INTRODUCTION 
 
Background 
Many factors contribute to the natural aging process during which an individual’s skin 
gradually loses its youthful appearance. Aging skin is characterized by loss of volume, 
decreased elasticity, and increased laxity. Clinical attempts to reverse or slow the aging 
process have employed a variety of aesthetic techniques. Long considered the gold 
standard, rhytidectomy is an effective, long-term solution for improving aesthetics of the 
aging face. However, more recently, there has been a focus on achieving skin tightening 
and soft tissue lift, approximating that of a surgical facelift, without the associated possible 
complications or extended recovery.[1] 
The facial rejuvenation market is rapidly advancing to accommodate the growing demand 
for such methods of skin lifting and tightening.[2] As a result, many products and 
procedures have been developed to treat facial rhytids and skin laxity. Traditional ablative 
chemical peels and dermabrasion were among the original approaches to improving fine 
lines and wrinkles.[3] The development of full-face laser ablation treatments followed [4], 
but their use has been limited by potential side effects and extended recovery time.[5]
Microneedling has also been introduced to improve the signs of skin aging, but this 
technique requires multiple sequential treatments, and it may take up to one year to achieve 
noticeable results.[6] 
Various energy-delivery devices have also been developed, and are designed to create 
thermal injury to stimulate fibroblast proliferation and collagen synthesis (e.g., fractionated 
ablative lasers, radiofrequency devices, fractional infrared devices).[7] However, most 
energy-based devices only produce tightening effects within superficial layers of the skin. 
Microfocused ultrasound (MFU) energy can provide deeper skin-tightening effects by 
focusing energy deposition in the dermis and subcutaneous tissue. Compared to epidermal 
treatments, ultrasound-energy use is associated with fewer adverse post-treatment effects 
as it can penetrate to deeper layers of skin and leave the epidermal layers and intervening 
skin tissues relatively unaffected.[8] 
The Ulthera® System is a non-invasive, dermatological, aesthetic treatment that is cleared 
by the United States Food and Drug Administration (FDA) to lift the eyebrow (FDA 
510(K) number: K072505), lift (K121700) and improve the appearance (K180623) of lax 
submental and neck tissue, and reduce wrinkles and lines in the décolleté (K134032). In 
previous clinical trials, the Ulthera System has demonstrated safety and effectiveness as a 
non-invasive aesthetic treatment. The Ulthera System utilizes MFU energy with 
visualization (MFU-V) to create thermal coagulation points (TCPs) in the deep reticular 
layer of the dermis and sub-dermis while leaving the epidermal layers and overlying 
papillary dermis unaffected.[9] These thermal microinjuries lead to collagen scaffold 
remodeling that lifts the overlying skin and tightens the dermal layers.[9, 10] Under the 
current FDA clearance, DeepSEE® transducers are used in combination with the Ulthera 
System to incorporate high-resolution ultrasound imaging with MFU therapy. With a tissue 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 21 of 93 
the skin as well as the overall appearance of the lower face and submentum by lifting the 
deeper soft tissue planes. 
Potential treatment site responses associated with the use of the Ulthera DeepSEE System 
reported in previous clinical trials of the Ulthera DeepSEE System include: erythema 
(redness), edema (swelling), welting (localized area of linear visible edema), momentary 
pain/discomfort during the procedure while energy is being deposited, post-procedure 
discomfort, tenderness to touch, bruising, transient nerve effects (e.g., numbness due to 
inflammation of a sensory nerve, pain, paresthesia, tingling, itching), and transient local 
muscle weakness due to inflammation of a motor nerve. The possibility for burns, which 
may or may not result in permanent scar formation, may occur if incorrect treatment 
technique is used (e.g., tilting transducer, incorrect line spacing, gel pockets). Some scars 
may respond to medical treatment and resolve fully. 
Adverse events (AE) have been reported in post-market surveillance following the 
commercialization of the Ulthera DeepSEE System. Because these events are reported 
voluntarily from a population of uncertain size, it is not always possible to reliably estimate 
their frequency or establish a causal relationship to the Ulthera DeepSEE System. 
These events have been chosen for inclusion due to a combination of their seriousness, 
frequency of reporting, or potential causal connection to the Ulthera DeepSEE System: 
pain, burns or burning sensation, edema / swelling, nodules, bruising, fat / volume loss, 
neuropathy, numbness, paresthesia, palsy, paresis, speech difficulty, muscle weakness, 
headache, migraine, visual change, skin sagging / drooping, asymmetry, erythema, welts, 
hives, rash urticaria, pruritis, blistering, scarring, discoloration, and hyperpigmentation. 
Risks will be minimized or reduced by monitoring the subject during treatment, with 
careful observation of the subject’s pain and skin response to treatment. Previous clinical 
trials with the Ulthera DeepSEE System have shown the sensory response was tolerable 
from both the subject’s and investigator’s perspective.[9] If a case arises whereby the 
treatment is not tolerated, the treating investigator has the option to reduce transducer 
energy level to improve treatment tolerability. If treatment tolerability is not improved 
following energy level reduction, the treating investigator may utilize additional measures 
to improve tolerability as described in Section 10.5.1.2. If treatment remains intolerable 
following the implementation of these measures, the treating investigator must stop 
administering treatment for the subject’s safety, and the subject will be followed for AEs 
throughout the trial duration. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 23 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 24 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 25 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 26 of 93 
7.2.2 
Safety Endpoints 
7.2.2.1 
Secondary Safety Endpoint 
• Incidence of treatment emergent adverse events (TEAEs) related to the Ulthera 
DeepSEE System, as reported by the treating investigator throughout the trial. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 30 of 93 
9.2.2 
Exclusion Criteria 
Subjects meeting any of the following criteria at screening (Day – 14 to – 3; V1) and Day 1 
(V2) are not eligible to participate in the trial: 
Scarring in area(s) to be treated. 
Any active implants (e.g., pacemakers or defibrillators) in the area(s) to be treated 
Any metallic implants in area(s) to be treated. 
Any open wounds or lesions
, in the area(s) to be 
treated. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 31 of 93 
Body mass index (BMI) less than 19 or greater than 30. 
Gain or loss of ≥ 2 BMI units within the previous 90 days or has the intention to gain 
or lose ≥ 2 BMI units during the course of the trial. 
                                                        

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 32 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 33 of 93 
9.2.4 
Subject Enrollment and Randomization 
Subjects are considered to be enrolled once the ICF is signed and dated. Eligible subjects 
will be randomized during the screening period (Day – 14 to – 3). Randomization 
assignment will not be disclosed to the subjects until Visit 2 (Day 1). 
Screen failures are defined in Section 9.2.5. 
9.2.5 
Screen Failures 
Subjects who provide informed consent but who do not meet eligibility criteria or who 
withdraw consent prior to being randomized will be defined as screen failures. 
The investigator will maintain all source documentation for all subjects who are considered 
screen failures. Minimal information will be collected in the electronic data capture (EDC) 
system for screen failures, such as date of informed consent, demographics, and reason for 
screen failure. Individuals who do not meet the criteria for participation in this trial 
(i.e., screen failure) will not be rescreened. 
9.2.6 
Removal of Subjects from Therapy or Assessment 
9.2.6.1 
Treatment Discontinuation 
If trial treatment is discontinued during administration, the investigator will record the 
reason for treatment discontinuation in the trial records. If the subject experiences 
escalating pain or discomfort during treatment with the Ulthera DeepSEE System that is 
not adequately controlled, the investigator may reduce transducer energy level to improve 
treatment tolerability (see Section 10.5.1.3). If subject pain or discomfort is not improved 
by energy level reduction, the investigator may use his/her discretion to suspend treatment 
to allow for additional pain management measures (see Section 10.5.1.2). Attempts should 
be made to optimize pain medication so that treatment can be completed. 
The investigator may request that a subject discontinuing treatment continue to participate 
in the trial and complete all remaining visits and assessments for safety follow-up. 
For subjects who decline to continue trial participation after treatment discontinuation, 
additional information regarding subject withdrawal is provided in Section 9.2.6.2. 
9.2.6.2 
Subject Withdrawal or Discontinuation 
Each subject will be followed to the end of trial (EOT), or until the sponsor decides to 
terminate the trial, whichever comes first. The only reasons a subject will not be followed 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 35 of 93 
9.2.7 
Suspension or Premature Termination of an Investigative Site  
Trial participation by individual sites may be suspended or prematurely terminated by the 
sponsor. Reasons for the suspension or premature termination of sites include, but are not 
limited to, the following: 
• Investigator request; 
• Serious or persistent noncompliance with the protocol, local regulations, and/or 
Chinese GCP; 
• Suspicion of fraud; 
• Failure to accrue subjects at an acceptable rate; and/or 
• Ethical issues. 
The sponsor will provide the investigative site with written notification documenting the 
reason for suspension or premature termination. The sponsor will inform the responsible 
regulatory authority, as appropriate, and ensure the IEC/IRB is notified. If the suspension 
or premature termination was in the interest of safety, the sponsor will inform all other 
principal investigators. 
In cases of temporary suspension at an investigative site, the sponsor will conduct an 
analysis of the reason(s) for suspension. After completing this analysis and implementing 
necessary corrective actions, a temporary site suspension may be lifted. The sponsor will 
inform the principal investigators, the IEC/IRB, and, where appropriate, the regulatory 
authority of the rationale, providing relevant data supporting this decision. 
Concurrence must be obtained from the IEC/IRB and, where appropriate, regulatory 
authorities before the investigative site resumes trial activities. If subjects were informed 
of the suspension, the principal investigator or authorized designee will inform them of the 
reasons for resumption. 
In cases of premature termination, the investigator will conduct site-closure activities in 
accordance with all applicable sponsor, local, and international guidelines and regulations. 
9.2.8 
Suspension or Premature Termination of the Trial 
Should the investigator, sponsor, the NMPA, or local regulatory authorities become aware 
of conditions arising during the conduct of this trial that may warrant the cessation of the 
trial, such action may be taken. Prior to such action, consultation between the sponsor, the 
investigator, and, as appropriate, the NMPA and/or local regulatory authorities will occur. 
Reasons for the suspension or premature termination of the trial include, but are not limited 
to, the following: 
• Anticipated benefit cannot justify the risk; 
• New scientific data do not justify a continuation of the trial; 
• Determination of a potential safety risk to subjects; 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 36 of 93 
• Inadequate subject enrollment; 
• Decision by the regulatory authority or IEC/IRB to suspend or terminate approval/ 
favorable opinion for the trial; and/or 
• Sponsor decision. 
If suspicion of an unacceptable risk to subjects arises during the trial or if instructed by the 
IEC/IRB or regulatory authorities, the sponsor will suspend the trial while the risk is 
assessed. If the analysis determines that implementing necessary corrective actions is 
sufficient, a temporary trial suspension may be lifted. If an unacceptable risk is confirmed, 
the sponsor will terminate the trial. 
If the trial is suspended or prematurely terminated for any reason, the sponsor will inform 
all 
investigators 
and 
relevant 
regulatory 
authorities 
promptly 
of 
the 
trial 
suspension/termination and reason for the action, as detailed in Section 9.2.7. 
The investigator will conduct site-closure activities in accordance with all applicable 
sponsor and local/international guidelines and regulations. 
9.2.9 
End of Trial 
The end of the trial is defined as when the last subject completes the last visit. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 38 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 39 of 93 
 Methods of Assigning Subjects to Trial Groups 
Subjects who complete all screening assessments and meet all eligibility criteria will be 
enrolled and randomized 1:1 to one of the following groups: 
− Treatment Group: Treatment with the Ulthera DeepSEE System at Day 1; or 
− Control Group: Untreated control, with delayed treatment at Day 90. 
Trial group assignments will be made based on the trial randomization scheme. 
A randomization list block-stratified by site will be created by a validated computerized 
randomization program. This randomization list will be uploaded to an electronic system 
that will allocate trial group assignment to the subjects in the eCRF according to the 
randomization list, if all relevant data were entered and the subject is eligible for 
participation in this trial. Randomized subjects will receive a unique randomization 
number, which will be recorded along with the date of randomization in the eCRF. 
This information will remain in the subject’s source documents and be made available for 
verification of the proper randomization sequence by the sponsor or designee during 
monitoring visits. 
Additional details regarding randomization are provided in Section 13.2. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 42 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 43 of 93 
 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 44 of 93 
10.5.2 
Selection and Timing of Treatment for Each Subject 
Subjects in the Treatment Group will receive a single treatment with the Ulthera DeepSEE 
System at Day 1 (V2). Subjects in the Control Group will not receive treatment at Day 1 
and will remain untreated until Day 90 (V3). Following completion of all 
protocol-mandated assessments at Day 90 (Section 11.1
), the Control 
Group will receive a single treatment with the Ulthera DeepSEE System. 
10.5.3 
Treatment Interruption and Modification 
If any problems occur during system operation, the treating investigator should take the 
following immediate action(s): lift the transducer off the subject’s skin, press the See 
button on the handle to discontinue treatment in progress, and/or press the red emergency 
Stop button to completely halt system operation. 
 Prior and Concomitant Therapy 
Medical history and concomitant therapy that is deemed relevant for study conduct by the 
investigator (e.g., chronic diseases, previous aesthetic treatments) should be documented 
in the eCRF. Restrictions regarding concomitant therapy are discussed in detail in 
Section 9.2.2 (Exclusion Criteria) and Section 9.2.3 (Restrictions during the Trial). 
Trial Supplies and Packaging of Treatment Supplies
The sponsor will provide the Ulthera DeepSEE System including console, handpiece, and 
transducers. This investigational medical device (IMD) is to be used exclusively for 
treatment of subjects enrolled in this trial and will be labeled as follows: “CAUTION - 
Investigational Device. Limited to Investigational Use Only.” Device labels will also note 
the sponsor name and address, manufacturer name and address, study number, the quantity 
within the package, and any other required information (if applicable). 
 
 
Sites will also be supplied with trial-specific ultrasound gel, cleanser for washing of the 
treatment area, 3D facial camera system (Section 11.2.1.2), and a standardized hand mirror 
for use during the FACE-Q and sGAIS assessments. Clinical trial supply should be stored 
in a controlled area with limited access and stored separately from any commercial 
supplies. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 45 of 93 
The sponsor will package trial materials according to applicable regulatory requirements. 
The sponsor will provide all pertinent labeling information, as well as a description of the 
specific device-packaging conditions. 
Parts of the trial device may be subject to reduced labeling according to the applicable 
regulations. Records about production date, serial number (as applicable), test record 
related to product quality, and records of transportation, maintenance, and delivery must 
be kept with the trial device. 
 Receipt, Storage, Dispensing, and Return 
Upon receipt, trial personnel will verify the contents of all supplies received and promptly 
notify the appropriate contacts of any discrepancies or damages. Only authorized trial 
personnel may administer trial treatment, and only subjects randomized in the trial may 
receive trial treatment. The investigator is responsible for ensuring an accurate record of 
inventory is maintained. The investigator or designee will keep a current record of the 
trial-device delivery to the trial site, inventory, and treatment dispensation, and this record 
will be made available to the sponsor upon request. Sites will be queried about any 
discrepancies. 
All trial devices must be stored in a secure area. 
After the last subject has received treatment, and after verification of device accountability, 
it is the investigator’s responsibility to return all used and unused IMD equipment (i.e., 
console, handpiece, and transducers) to the local depot. Appropriate records of return must 
be maintained for accountability purposes. 
All device-accountability procedures must be completed before the trial is considered 
complete. 
 Device Accountability Procedures 
All necessary trial supplies will be released to the investigator before site initiation at the 
latest. Accountability for trial supplies at the trial site is the responsibility of the 
investigator. 
Access to the IMD will be controlled, and the IMD will be used only in the clinical trial 
and according to the CTP. The sponsor will keep records to document the physical location 
of all IMDs from shipment to the investigative sites until return. The investigator or an 
authorized designee is responsible for ensuring accurate records of receipt, use, and return 
of the IMD, are maintained and include: 
• The date of receipt and quantity of units received. 
• Identification of each IMD (batch number/serial number or unique code). 
• The expiry date (if applicable). 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 46 of 93 
• The names of all persons who received or used each device. 
• The date or dates of use and time. 
• Subject identification. 
• Date of return of used, unused, expired, or malfunctioning IMDs (if applicable). 
Dispensing records (i.e., treatment lines administered, and energy levels used) are recorded 
on the subject’s treatment record, which is automatically generated by the Ulthera 
DeepSEE System. These data will be transferred to the EDC system. An overall 
accountability log will be maintained for each subject, documenting the number of 
treatment lines administered as well as energy levels used in each treatment region. 
All used and unused IMD equipment must be returned to the local depot immediately after 
the trial is completed (Section 10.8). Products destroyed during shipment or at an 
investigative site should be accounted for and documented. All clinical supplies must be 
accounted for at the termination of the trial and a written explanation provided for 
discrepancies. 
Treatment Compliance 
All treatments will be administered by the primary treating investigator or designated 
back-up treating investigators; therefore, assessment of compliance is unnecessary. 
Variations from the defined trial-treatment administration will be reported as protocol 
deviations. 
Duration of Trial 
Subjects will have a screening period up to 14 days and participate for a maximum duration 
of 180 days (± 14 days) after treatment. 
The estimated trial duration from first subject, first visit (FSFV) to last subject, last visit 
(LSLV) will be approximately 15 months, including an estimated 9 months for subject 
recruitment to complete. The actual duration of the study will be calculated according to 
the actual date of the Clinical Study Report stamp. 
 
 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 48 of 93 
11.1.1 
Scheduled Visits
All scheduled visits and applicable trial assessments must occur as noted in Section 11.1
and the Schedule of Events
.
11.1.2 
Unscheduled Visits 
To ensure subject safety, any subject who, for any reason, requires additional follow-up 
that does not coincide with a scheduled trial visit should have that visit recorded as an 
unscheduled visit, during which concomitant medication/procedures and AEs must be 
assessed and recorded. 
An unscheduled visit must be scheduled if information acquired from a subject during a 
post-treatment phone call, 
requires additional 
follow-up as determined by the investigator. 
 Trial Assessments and Definitions 
11.2.1 
Effectiveness Assessments 
The effectiveness the Ulthera DeepSEE System for the treatment of skin laxity in the lower 
face and submental area will be evaluated using several assessments. Refer to the 
respective endpoints (Section 7.2), visit schedule (Section 11.1
), and 
Schedule of Events 
for additional information on the methods and timing 
of effectiveness assessments. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 49 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 50 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 51 of 93 
11.2.1.4 
FACE-Q Assessment 
FACE-Q is a set of validated, standardized patient-reported outcome scales for subjects 
receiving facial cosmetic procedures. [14-16] In this trial, subjects will evaluate treatment 
outcomes using the FACE-Q Satisfaction with Lower Face and Jawline instrument 
. Subjects will utilize a mirror when answering the FACE-Q questionnaire. 
Standardized mirrors will be provided to sites to ensure subjects are utilizing the same type 
of mirror (i.e., standard size, shape, etc.). 
For each subject, a sum score (range: 5 to 20) will be calculated; higher scores indicate a 
better outcome. Sum scores will then be Rasch-transformed (range: 0 to 100)
 
 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 53 of 93 
Serious AEs occurring after the end of the observational period only need to be reported if 
the investigator considers the SAE to be related to the investigational device. These reports 
generally will not be entered into the clinical database. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 54 of 93 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 55 of 93 
11.2.3 
Additional Data Collected 
Data for other assessments will be collected as follows: 
• Demographics and other baseline characteristics, including height and weight; 
• Dispensing records (i.e., treatment lines administered, and energy levels used); 
• Relevant medical history/concomitant diseases; 
• Concomitant medications and non-drug treatments; and 
• Vital signs. 
 
 
11.2.3.2 
Vital Signs 
Vital signs will be measured on all subjects after they have been seated for approximately 
five minutes. Resting heart rate and blood pressure (systolic and diastolic, preferably on 
the same arm each time) will be measured at screening (V1) and at the End of Trial Visit 
(V4). 
 
11.2.4 
Appropriateness of Assessments 
Appropriateness of the selected trial assessments is detailed in the respective Effectiveness 
Assessments (Section 11.2.1) and Safety Assessments (Section 11.2.2). 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 57 of 93 
record any AE in detail in the subject’s file and on the AE eCRF. The following information 
must be recorded: 
• AE diagnosis or main symptom; 
• AE localization (restricted to treatment area, systemic). If a local reaction, the 
corresponding area should be reported; 
• Date of onset; 
• Intensity (maximum observed using the Severity Grading scale; Section 12.1.3); 
• Causal relationship (not related, related) to investigational device and study procedure; 
• Serious (yes, no), date serious since, and reason for seriousness; 
• Outcome (Section 12.1.5); 
• AE leading to discontinuation of the clinical trial (yes, no); 
• Action taken with medical device; 
• Action taken related to the AE; and 
• Stop date. 
In cases of an SAE (defined in Section 12.2), the investigator must also complete an SAE 
Report Form and report it to the sponsor and CRO immediately as described in 
Section 12.2.2. 
12.1.3 
Severity Grading for an AE 
The clinical severity (i.e., intensity) of an AE will be classified as: 
Mild: 
Signs and symptoms that can be easily tolerated. Symptoms can be ignored 
and disappear when the subject is distracted. 
Moderate: Signs and symptoms that cause discomfort and interfere with normal 
functioning but are tolerable. They cannot be ignored and do not disappear 
when the subject is distracted. 
Severe: 
Signs and symptoms that affect usual daily activity and incapacitate the 
subject, thereby interrupting daily activities. 
The investigator is required to grade the severity (i.e., intensity) of each AE. 
12.1.4 
Causal Relationship of an AE with an Investigational Medical 
Device 
An AE is considered to be “related” to IMD or to the treatment procedure if a causal 
relationship between the IMD or the treatment procedure and an AE is at least reasonably 
possible (i.e., the relationship cannot be ruled out). In this case, the non-serious event is 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 58 of 93 
considered an “adverse device effect” (Section 12.3). If the event is serious, it is a “serious 
adverse device effect” (Section 12.4). 
The expression “reasonable causal relationship” is meant to convey that there are facts 
(evidence) or arguments to suggest a causal relationship. Otherwise, the relationship should 
be considered as “not related”. 
12.1.5 
Outcome Categories for an AE
Reportable outcomes and/or sequelae of an AE may include the following: 
• Recovered/resolved; 
• Recovering/resolving; 
• Not recovered/not resolved; 
• Recovered/resolved with sequelae; 
• Fatal; or 
• Unknown. 
If there is more than one AE, only the AE leading to death will be attributed with a “fatal” 
outcome. 
 Definition of a Serious Adverse Event (SAE) 
An SAE is an adverse event that: 
a) led to death; 
b) led to serious deterioration in the health of the subject, that either resulted in: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function including 
chronic diseases, or 
3) inpatient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
c) led to fetal distress, fetal death, or a congenital abnormality or birth defect including 
physical or mental impairment. 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the 
CTP, without serious deterioration in health, is not considered an SAE. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 59 of 93 
12.2.1 
Details of an SAE 
In cases of fatality, the cause of death is considered the AE, and the death is considered its 
outcome. In this case, the primary cause of death (i.e., the event leading to death) should 
be recorded and reported as an SAE. “Death” will be recorded as the outcome of this 
respective event; death will not be recorded as a separate event. Only if no cause of death 
can be reported (e.g., sudden death, unexplained death), the death per se might be reported 
as an SAE. In cases of death, an autopsy report should be submitted (if available). The date 
and cause of death should be recorded. 
Planned hospitalization for a pre-existing condition is not considered an SAE. If a subject 
experiences an additional AE that prolongs a pre-planned hospitalization, this event is 
considered an SAE and should be reported as such. Hospitalizations for elective treatments 
planned before screening and which are documented in the subject’s source data are usually 
not regarded as SAEs. 
In addition, device deficiencies, as defined in Section 12.5, that might have led to an SAE 
if: 
a) suitable action had not been taken; or 
b) intervention had not been made; or 
c) if circumstances had been less fortunate 
should be categorized as an SAE and reported accordingly. 
12.2.2 
Reporting and Handling of an SAE 
All SAEs that occur during the clinical trial period, whether considered to be related to the 
IMD or not, must be reported via fax, phone, or e-mail, and an SAE Report Form should 
be submitted to the sponsor and the CRO immediately upon knowledge of the event. 
The investigator will report the SAE to the clinical trial management departments of the 
clinical trial institution and the CRO. Further reporting details will be outlined in the Safety 
Management Plan. 
Although all information required for completion of an SAE Report Form may not be 
available within the specified time period, an initial report should be submitted if the 
following minimal information is available: 
• An identifiable subject (unique subject number); 
• A suspect product and how the treatment relates to the SAE; 
• An identifiable reporting source (investigator/investigative site identification); and/or 
• An event or outcome that can be identified as serious. 
The investigator must report SAEs to the sponsor and the CRO, as defined in Section 12.2, 
and in compliance with Chinese GCP (Article 71), and to the site’s IEC/IRB, through the 
medical device clinical trial management department, per their reporting guidelines. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 61 of 93 
 Definition of an Adverse Device Effect (ADE) 
An ADE is defined as an adverse event related to the use of an IMD. 
Note: 
1. This definition includes AEs resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or operation or any malfunction of the 
IMD. 
2. This definition includes any event resulting from use error or from intentional misuse 
of the IMD. 
 Definition of a Serious Adverse Device Effect (SADE) 
An SADE is defined as an adverse device effect that has resulted in any of the consequences 
characteristic of an SAE (Section 12.2). 
12.4.1 
Definition of an Anticipated Serious Adverse Device Effect 
(ASADE) 
An ASADE is a serious adverse device effect which, by its nature, incidence, severity, or 
outcome, has been identified in the current version of the risk-analysis report. 
12.4.2 
Definition of an Unanticipated Serious Adverse Device Effect 
(USADE) 
A USADE is defined as follows: 
• Any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational 
plan or application (including a supplementary plan or application), risk-analysis 
report, or IFU. 
•
Any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects. 
 Reporting of Pregnancy 
Any pregnancy that starts during the clinical trial must be reported by the investigator to 
the sponsor and CRO immediately. Pregnancies and pregnancy follow-up should be 
reported on a Pregnancy Form. Pregnancy follow-up should describe the outcome of the 
pregnancy, including any voluntary or spontaneous discontinuation; details of the birth; the 
presence or absence of any congenital abnormalities, birth defects, maternal or newborn 
complications, and their relation to the IMD. In addition, each pregnancy has to be reported 
on the AE eCRF page (i.e., as a non-serious AE due to device exposure before or during 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 62 of 93 
pregnancy). Pregnancy Forms (including any follow-up forms) should be submitted to the 
contacts referenced in Section 12.2.2. 
If a subject becomes pregnant during the trial, the subject must not receive treatment 
(i.e., delayed treatment for subjects in the Control Group); however, the subject will remain 
in the trial. 
 Definition of Device Deficiency 
A device deficiency is defined as an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety, or effectiveness. 
Note: Device deficiencies include malfunctions, use errors, and inadequate labeling. 
12.7.1 
Reporting and Handling of Device Deficiencies 
All device deficiencies shall be documented and reported by the investigator throughout 
the clinical trial and appropriately managed by the sponsor. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 64 of 93 
13 STATISTICAL METHODS 
This section describes the statistical analyses foreseen at the time of trial planning. 
Further details on the statistical and analytical aspects will be presented in the statistical 
analysis plan (SAP) that will be prepared and completed prior to database close. 
Any deviations from planned analyses, the reasons for such deviation, and all alternative 
or additional statistical analyses that may be performed before database close will be 
described in amendments to the CTP and/or the SAP. All deviations and/or alterations will 
also be summarized in the clinical trial report. 
 Randomization 
Each subject screened will be given a screening number. Only the subjects who are 
randomized will receive a randomization number during the screening period (Day – 14 to 
– 3). Subjects are randomized balanced (1:1) to one of the following groups: 
• Treatment Group: Treatment with the Ulthera DeepSEE System at Day 1; or 
• Control Group: Untreated control, with delayed treatment at Day 90. 
Randomization will be stratified by investigative site and performed in blocks. All 
randomization codes will be generated by an electronic system. The system will allocate 
the subject’s randomization number and will determine the subject’s group assignment 
(Treatment Group or Control Group). The randomization number for each subject will then 
be recorded in the eCRF. 
See Section 10.3 for additional details on randomization. 
 Populations for Analysis 
The following analysis sets will be defined: 
• The randomized set is defined as all subjects randomized into the trial; 
• The Safety Evaluation Set (SES) is defined as all subjects treated; 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 67 of 93 
13.4.2 
Safety Analyses 
All safety endpoints will be analyzed for the SES. Subjects will be analyzed as treated. 
Moreover, safety analyses will be based on the pooled randomized groups if not otherwise 
specified. 
Adverse events will be coded according to the Medical Dictionary for Regulatory 
Activities (MedDRA) version that is in effect at the time the database is closed to allow for 
analysis by System Organ Class (SOC) and Preferred Term (PT). 
13.4.2.1 
Secondary Safety Endpoints 
The secondary safety endpoints are defined in Section 7.2.2.1. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 69 of 93 
 Special Statistical/Analytical Issues 
13.5.1 
Subject Discontinuation and Missing Data 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 70 of 93 
13.5.2 
Interim Analyses 
No interim analyses are intended. 
13.5.3 
Multiple Comparisons/Multiplicity 
No multiplicity adjustments are intended. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 71 of 93 
14 ADMINISTRATIVE PROCEDURES 
 Trial Monitoring 
Trial monitoring will conform to all applicable regulatory standards and guidelines. 
The sponsor or designee will monitor the trial through periodic site visits to verify: 
• Data authenticity, accuracy, and completeness; 
• Protection of subject rights and safety; and 
• Conduct of the trial is in accordance with the currently approved protocol and all 
applicatory regulatory and IEC/IRB requirements and guidelines. 
Investigators agree to grant access to all relevant documents and provide support at all 
times for trial-monitoring activities. These activities will be performed in a manner that 
ensures maintenance of subject confidentiality (Section 5.3 and Section 5.4). 
Further details of monitoring activities will be provided in the monitoring manual. 
 Data Quality Assurance and Standardization Procedures 
Inspections by regulatory-authority representatives and institutions are possible at any 
time, even after the end of trial. The investigator is to notify the sponsor immediately of 
any such inspection. The investigator and institution will permit trial-related monitoring, 
audits, and/or reviews by the regulatory authorities and will allow direct access to source 
data and source documents for such monitoring, audits, and reviews. 
Standardization procedures will be implemented to ensure accurate, consistent, complete, 
and reliable data, including methods to ensure standardization among sites (e.g., training, 
newsletters, investigator meetings, monitoring, evaluations, and validation methods).
This trial will be monitored regularly by a qualified monitor from the CRO according to 
EN ISO 14155, Chinese GCP, Chinese regulatory authority requirements, and the 
respective standard operating procedures (SOPs; Section 14.1). 
 Source Documentation Requirements 
All data collected from a subject during the course of a clinical investigation should be 
retained in the respective source documentation (e.g., subject file). Although not an 
exhaustive list, this information should include a descriptive statement on the informed 
consent procedure (Section 5.2). The investigator must also confirm by written statement 
in the source documentation that all inclusion criteria and all exclusion criteria were 
checked prior to inclusion of the subject. In addition to this statement, the subject’s meeting 
or non-meeting of the in- and exclusion criteria and eligibility criteria must be traceable in 
the source documentation. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 73 of 93 
All data required by this CTP are to be recorded in the eCRF as soon as possible. 
However, direct entries are not allowed; data must be transcribed from the source 
documentation (e.g., subject file, scales) to the eCRF. 
If eCRF corrections are necessary, an authorized member of the investigator’s trial 
personnel will enter the correct data into the web-based eCRF. The audit trail in the EDC 
system documents all changes. 
The CRO’s and sponsor’s data-management functions will be responsible for data 
processing, in accordance with the CRO’s and sponsor’s data-management procedures. 
Database close will occur only after quality-assurance procedures have been completed. 
Entries from questionnaires (e.g., 
FACE-Q; subject GAIS) completed by the 
subject will be entered into the eCRF by trial personnel. If corrections in the questionnaires 
are necessary, the subject should be instructed to make a correction by drawing only a 
single line through the error, leaving the incorrect entry legible. The subject should date 
and initial the correction. The investigator should not make any changes to these 
documents. Per Chinese GCP, clinical trial records, as the original materials, must not be 
changed without authorization. If such a change is required, the reason shall be explained, 
and the explanation shall be signed and dated. 
14.3.3 
Direct Access to Source Data/Documents 
As stated in Section 14.1, investigators agree to grant access to all relevant documents and 
to provide support for monitoring activities. 
Subjects providing informed consent (Section 5.2) agree to allow the sponsor or designee 
access and copying rights to pertinent information in their medical records concerning their 
participation in this trial. The investigator will obtain, as part of the informed consent, 
permission for trial monitors or regulatory authorities to review, in confidence, any records 
identifying the subjects in this trial. This information may be shared with regulatory 
agencies; however, the sponsor undertakes not to otherwise release the subject’s personal 
and/or private information. 
14.3.4 
Auditing 
Audits shall be conducted by qualified auditors to evaluate compliance with the CTP, 
sponsor’s current written procedures, and any applicable regulatory requirements. 
These audits may cover all involved parties, systems, and facilities and are independent of, 
and separate from, routine monitoring or quality-control functions. 
An audit can be conducted: 
a) as a routine part of the sponsor’s quality-assurance program; 
b) to assess the conduct of the monitoring activity; 
c) whenever there are serious or repeated CTP deviations or suspicion of fraud; 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 74 of 93 
d) to bring an investigative site into “inspection readiness” (i.e., to prepare the 
investigative site for a potential regulatory inspection), and/or 
e) when requested or suggested by a regulatory authority. 
Audit results shall be documented and communicated to relevant parties, if applicable. 
 Protocol Deviations and Amendments 
14.4.1
Protocol Deviations 
Investigators will not deviate from or alter the CTP without written agreement between the 
principal investigator and the sponsor and written approval by the IEC/IRB based on prior 
review. Exceptionally, in case of urgent clinical need (e.g., to minimize emergent risk to a 
subject), the principal investigator may deviate from the protocol without this written 
agreement. After mitigating the immediate risk, the investigator must contact the sponsor 
and the CRO without delay to report the incident. 
In the event that an investigator does not comply with the Clinical Trial Agreement or the 
CTP, the sponsor will be notified of the site’s noncompliance. 
In the event of repeated noncompliance, as determined by the sponsor, a sponsor’s monitor 
or company representative will attempt to secure compliance by one or more of (and not 
limited to) the following: 
• Visiting the investigator; 
• Telephoning the investigator; and/or 
• Corresponding with the investigator. 
Repeated noncompliance with the signed Clinical Trial Agreement, the CTP, or any other 
conditions of the trial may result in further escalation in accordance with the sponsor’s 
written procedures, including securing compliance or, at its sole discretion, the sponsor 
may terminate the investigator’s participation in the trial. 
If CTP deviations occur at the investigative site, these will be detected during routine 
monitoring visits and reported in the visit report. In addition, a list containing all deviations 
reported from monitoring visits will be maintained by the CRO, analyzed for frequency 
and severity, and discussed with the sponsor on a regular basis. Depending on the type of 
deviation, corrective and preventive actions will be defined and implemented accordingly. 
14.4.2 
Protocol Amendments 
Approved CTP amendments will be provided to investigators by the sponsor. The principal 
investigator is responsible for notifying the IRB/IEC of the CTP amendment (if 
administrative changes) or obtaining IRB/IEC’s approval of the CTP amendment (if 
changes in subject care or safety), according to instructions provided by the sponsor. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 75 of 93 
Acknowledgement/approval by the IRB/IEC must be documented in writing prior to 
implementation of the CTP amendment. Copies of this documentation must also be 
provided to the sponsor. 
 Record Retention 
Essential documents should be retained per applicable regulations and as instructed by the 
sponsor. Essential documents at the investigative site include, but are not limited to: 
• Source documentation (e.g., subject files); 
• Subject identification code list (i.e., provided by template to the investigator, along 
with the Investigator Site File, at the beginning of the investigation), which identifies 
the subject by number, name, and date of birth; 
• A copy of the CTP and any amendments; 
• A CD/DVD with eCRF data and any associated subject-related source data (or, where 
applicable, authorized copies of source data); 
• Signed ICFs; 
• Copies of site investigators’ and co-workers’ curricula vitae; 
• Copies of all direct correspondence with the IEC/IRB and with the regulatory 
authority(ies); 
• Copies of all relevant correspondence between the investigator and the monitor and 
between the investigator and the sponsor; 
• Copies of investigational device disposition records; and 
• Copies of safety information reported during the investigation and submitted by the 
sponsor. 
Trial documents may not be destroyed by site personnel prior to the end of the required 
retention period, as specified by local regulations. The investigator or the institution must 
inform the sponsor in due time if the investigator leaves the institution during the retention 
period. This rule also applies when the institution closes within the retention period. 
Upon closure of the trial, the investigator must maintain all trial-site records in a safe and 
secure location. The investigator is responsible for the integrity, retention, and security of 
all trial-related records. The investigator must ensure that any reproductions of the original 
records are legible and provide a true and accurate copy of the original. Accurate, complete, 
and current records must be stored in a manner to permit easy and timely retrieval for the 
sponsor or any applicable regulatory authorities. 
The sponsor will inform the investigator of the time period for retaining these records to 
comply with all applicable regulatory requirements, with the minimum retention time being 
the longest of those times dictated by institutional requirements, local laws or regulations, 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 76 of 93 
or the sponsor’s standard procedures. The investigator must notify the sponsor in the event 
of any changes to archival arrangements due to withdrawal of the investigator’s 
responsibility for keeping trial records to ensure that suitable arrangements for the retention 
of trial records are made. 
 Clinical Trial Report 
A clinical trial report containing effectiveness and safety analyses will be generated after 
all subjects have completed the Day 180 visit. The content of the report will meet China 
Center of Medical Device Evaluation (CMDE) requirements. 
 Publication of Trial Results 
The results of this trial and any discoveries related to this trial, regardless of whether they 
have technical or medical character, are the property of the sponsor. 
The CTP, trial data, and information related to the trial or the sponsor’s products or research 
programs are to be kept confidential and may not be disclosed without the consent of the 
sponsor. 
The investigator agrees that the results of this trial may be used for submission to national 
or international registration and supervising authorities. Upon completion of the trial, 
publication or disclosure of trial results is to follow the terms contained in the sponsor’s 
publication policy. 
The sponsor will ensure the clinical trial is registered, and results are reported in public 
registries, at minimum in case one or both is required by law and/or other applicable 
requirements (e.g., on ClinicalTrials.gov if required by U.S. law and/or on Chinese Clinical 
Trial registry (ChiCTR)). Trial registration may include a list of investigative sites, as 
applicable. 
 Financial Disclosure 
Financial aspects of the investigation will be documented in an agreement between the 
sponsor, the CRO, and each investigator or any other involved party, and must be 
confirmed in writing before the investigation commences. 
 Investigator Compliance 
The investigator will conduct the trial in compliance with the CTP, EN ISO 14155, Chinese 
GCP, the Declaration of Helsinki, and Chinese regulatory authority requirements. 
Additional information is reported in Section 14.4.1. 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 77 of 93 
15 REFERENCE LIST 
1. Chan NP, Shek SY, Yu CS, Ho SG, Yeung CK, Chan HH. Safety study of 
transcutaneous focused ultrasound for non-invasive skin tightening in Asians. Lasers Surg 
Med. 2011;43(5):366-75. 
2. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. Clin Cosmet 
Investig Dermatol. 2015;8:47-52. 
3. Mulholland RS. Radio frequency energy for non-invasive and minimally invasive skin 
tightening. Clin Plast Surg. 2011;38(3):437-48, vi. 
4. Fitzpatrick RE. CO2 laser resurfacing. Dermatol Clin. 2001;19(3):443-51, viii. 
5. Nanni CA, Alster TS. Complications of carbon dioxide laser resurfacing. An evaluation 
of 500 patients. Dermatol Surg. 1998;24(3):315-20. 
6. Ablon G. Safety and Effectiveness of an Automated Microneedling Device in 
Improving the Signs of Aging Skin. J Clin Aesthet Dermatol. 2018;11(8):29-34. 
7. Sadick N. Tissue tightening technologies: fact or fiction. Aesthet Surg J. 
2008;28(2):180-8. 
8. Oni G, Hoxworth R, Teotia S, Brown S, Kenkel JM. Evaluation of a microfocused 
ultrasound system for improving skin laxity and tightening in the lower face. Aesthet Surg 
J. 2014;34(7):1099-110. 
9. Hitchcock TM, Dobke MK. Review of the safety profile for microfocused ultrasound 
with visualization. J Cosmet Dermatol. 2014;13(4):329-35. 
10. 
Dobke MK, Hitchcock T, Misell L, Sasaki GH. Tissue restructuring by energy-based 
surgical tools. Clin Plast Surg. 2012;39(4):399-408. 
11. 
Valizadeh N, Jalaly NY, Zarghampour M, Barikbin B, Haghighatkhah HR. 
Evaluation of safety and efficacy of 980-nm diode laser-assisted lipolysis versus traditional 
liposuction for submental rejuvenation: A randomized clinical trial. J Cosmet Laser Ther. 
2016;18(1):41-5. 
12. 
Coleman S. Structural fat grafting: Thieme Medical Publishers, Incorporated; 2004. 
13. 
Fabi SG, Joseph J, Sevi J, Green JB, Peterson JD. Optimizing Patient Outcomes by 
Customizing Treatment With Microfocused Ultrasound With Visualization: Gold Standard 
Consensus Guidelines from an Expert Panel. J Drugs Dermatol. 2019;18(5):426-32. 
14. 
Klassen AF, Cano SJ, Scott A, Snell L, Pusic AL. Measuring patient-reported 
outcomes in facial aesthetic patients: development of the FACE-Q. Facial Plast Surg. 
2010;26(4):303-9. 
15. 
Pusic AL, Klassen AF, Scott AM, Cano SJ. Development and psychometric 
evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported 
outcome instrument for facial aesthetics patients. Clin Plast Surg. 2013;40(2):249-60. 
16. 
Klassen AF, Cano SJ, Scott AM, Pusic AL. Measuring outcomes that matter to face-
lift patients: development and validation of FACE-Q appearance appraisal scales and 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 78 of 93 
adverse effects checklist for the lower face and neck. Plast Reconstr Surg. 2014;133(1):21-
30. 
17. 
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual 
Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill 
Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic 
Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of 
Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis care & research. 2011;63 
Suppl 11:S240-52. 
 

Ulthera, Inc., a division of Merz North America, Inc. 
CLINICAL TRIAL PROTOCOL 
M960101056 
 Version 3.0, 08-JUL-2021 
CONFIDENTIAL AND PROPRIETARY 
Page 79 of 93 
16 APPENDICES