Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Conditions: Rotator Cuff Tear Arthropathy, Osteoporosis, Osteomalacia, Joint; Destruction, Sacroiliac
Sponsor: Zimmer Biomet

FINAL 
FINAL 
FINAL 
1 
 
 
COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate 
PROTOCOL  
 
PROTOCOL NUMBER (Study ID): INT.CR.GE1 
PROTOCOL VERSION: V.  July, 31, 2014 
 
Purpose and Objectives 
 
The primary objective of this prospective clinical data collection is to evaluate survivorship 
for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.  Secondary objectives 
include validation of implant sizing and hardware options as well as collection of mid-term 
clinical outcomes including adverse events, scapular notching, and Constant Score.  
 
All shoulders on which data will be collected are legally marketed and none of the devices 
are investigational or experimental.  FDA has cleared this device via Premarket Notification 
510(k) K080642.  This data collection effort will document the clinical outcomes of the 
Comprehensive® Reverse shoulders.  The data gathered will be collated and used to 
provide feedback to designing engineers, support marketing efforts, and answer potential 
questions from reimbursement agencies.   
 
Inclusion/exclusion criteria are the same as the indications and contraindications stated in 
the labeling.  Surgical techniques and patient care are to be standard for the surgeon 
participating in the protocol. There will be no experimental or investigational surgical 
techniques used.  The devices and products are to be used in accordance with their 
instructions for use and/or approved labeling. 
 
The outcomes and data collected include: 
• 
Survivorship (including glenoid loosening) 
• 
Adverse Events (including dislocation) 
• 
Constant-Murley Shoulder Score 
• 
Radiographic Evaluation (Plain X-ray and CT) 
• 
Scapular Notching 
• 
American Shoulder and Elbow Surgeons (ASES) Assessment 
• 
Visual Analogue Scale (VAS) for patient satisfaction 
 
 
Survivorship will be documented by asking the surgeon to record revisions, complications, 
and device related events. 
 
Project Overview 
 
One-hundred (100) cases will be enrolled in this data collection effort and 3-year follow-up 
will be attempted.  Follow-up will be scheduled for 0 - 6 weeks, 6 months, 1 year and 3 
years post operatively.  Follow-up assessments include the Modified Constant shoulder 

FINAL 
FINAL 
FINAL 
2 
 
assessment, American Shoulder and Elbow Surgeon Assessment (ASES), VAS for patient 
satisfaction, and Radiographic Evaluation (plain radiographs and CTs). 
 
Patient Population 
 
A sample size of 100 Comprehensive® Reverse Shoulder cases which utilize the Mini 
Baseplate and mini stem will be sought for the study.  Bilateral shoulders may be included 
in the study as separate cases.  Any case requiring removal of any component will be 
considered a failure and the revised shoulder may be enrolled into the study as a new case. 
 
An effort will be made to obtain consecutive cases from each site.  However, because the 
patients have the right to refuse to participate in the study but still receive a 
Comprehensive® Reverse Shoulder, consecutive cases may not be achieved. 
 
 
Sample Size Calculation / Justification 
 
Because this is a one-arm observational study with no control group the sample size for this study 
is based on the goal of having a reasonable number of cases for evaluating device survival over 
the first 3 years of follow-up.  An article by Frederick Dorey, et. al. in the Journal of Arthroplasty 
recommends having greater than 20 subjects in follow-up when estimating survivorship1.  Other 
device registries use a population of 40 as a “rule of thumb” for survivorship analysis.  Loss to 
follow-up for this study is estimated to be 10% per year.  Thus, if 100 patients are enrolled, there 
will be 73 patients at 3 years of follow-up.   
 
Start with 100 cases and assume a loss of 10% per year 
 
1-year:      100  – 10 = 90 
2-year:        90  –   9 = 81 
3-year:        81  –   8 = 73 
 
Therefore, a starting population of 100 cases will be more than adequate to provide a 
reasonable evaluation of survivorship at 3 years per Dorey, et. al. 
 
 
This sample size is adequate to provide a precise estimate of the mean Constant 
score at the 3-year time point.  The “precision” is based on a 95% confidence 
interval, calculated based on the normal distribution, for the mean Constant score at 
3 years, and refers to the distance from the estimated parameter (point estimate) to 
the upper and lower limits of the confidence interval.  The full width of the 
confidence interval is twice the precision.  In an article by Ballas, et al.2, the standard 
deviation of the postoperative constant scores for 56 reverse shoulders at a mean 
follow-up of 58 months was 12 points.  Assuming a standard deviation of 12 points 
                                                 
1 Dorey, Frederick and Harlan C. Amstutz.  “Survivorship Analysis in the Evaluation of Joint Replacement.”  Journal of Arthroplasty.  Vol. 1 
No. 1, March 1986.pp 63-69. 
2 Ballas, Richard et al.  “Results of a stemless reverse shoulder prosthesis at more than 58 months mean without loosening.”   J Shoulder 
Elbow Surg (2013) 

FINAL 
FINAL 
FINAL 
3 
 
and 73 patients available at the 3 year follow-up, the precision of a 95% confidence 
interval for the mean would be +/- 2.8 points. 
 
 
Inclusion Criteria 
 
The inclusion criteria are the same as the indications stated in the cleared labeling for the 
device, specifically: 
 
 
Biomet® Comprehensive® Reverse Shoulder products are indicated for use in  
patients whose shoulder joint has a grossly deficient rotator cuff with severe 
arthropathy and/or previously failed shoulder joint replacement with a grossly 
deficient rotator cuff. The patient must be anatomically and structurally suited to 
receive the implants and a functional deltoid muscle is necessary.  
 
The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision 
total shoulder replacement for the relief of pain and significant disability due to gross 
rotator cuff deficiency.  
 
Glenoid components with Hydroxyapatite (HA) coating applied over the porous 
coating are indicated only for uncemented biological fixation applications. The Glenoid 
Baseplate components are intended for cementless application with the addition of 
screw fixation.  
 
Interlok™ finish humeral stems are intended for cemented use and the MacroBond™ 
coated humeral stems are intended for press-fit or cemented applications. Humeral 
components with porous coated surface coating are indicated for either cemented or 
uncemented biological fixation applications. 
 
 
Therefore, patients / cases to be included in this study shall utilize the following inclusion 
criteria: 
 
1. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse 
shoulder configuration.   
2. The patient must be anatomically and structurally suited to receive the implants and 
a functional deltoid muscle is necessary.  
3. Grossly deficient rotator cuff with severe arthropathy and/or  
a. Previously failed shoulder joint replacement with a grossly deficient rotator 
cuff.  
b. Primary total shoulder replacement for the relief of pain and significant 
disability due to gross rotator cuff deficiency, or 
c. Fracture total shoulder replacement for the relief of pain and significant 
disability due to gross rotator cuff deficiency, or 
d. Revision total shoulder replacement for the relief of pain and significant 
disability due to gross rotator cuff deficiency. 

FINAL 
FINAL 
FINAL 
4 
 
 
 
Exclusion Criteria 
 
The exclusion criteria are the same as the indications stated in the cleared labeling for the 
device: 
 
Absolute contraindications include infection, sepsis, and osteomyelitis. 
 
Relative contraindications include: 
1. 
Uncooperative patient or patient with neurologic disorders who is incapable or  
 
unwilling to follow directions. 
2. 
Osteoporosis. 
3. 
Metabolic disorders which may impair bone formation. 
4. 
Osteomalacia. 
5. 
Distant foci of infections which may spread to the implant site. 
6. 
Rapid joint destruction, marked bone loss or bone resorption apparent on 
 
roentgenogram. 
 
HIPAA Compliance 
 
Compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
is required and data collection must comply with the Standards for Privacy of Individually 
Identifiable Health Information, 45 CFR Part 160 and Part 164, as amended from time to 
time (the “Privacy Rule”), under HIPAA. 
 
The case report forms do not include any patient identifying information in accordance 
with HIPAA.  Therefore, once the data is entered in the online database a patient can no 
longer be identified.  It is the responsibility of the investigator to maintain a list of patient 
identification and Joint Assist ID numbers. 
 
By assigning patients a unique Joint Assist ID number, their identity is protected in Joint 
Assist, the online database.  The database is restricted, allowing a doctor to only view and 
enter data from his own patients.  User authentication is required to view research data.  
The data is transmitted to a centralized database through a secured (SSL) channel on the 
Internet.  Data in transit is in 128-bit encryption.  The access to the centralized database is 
limited to those who are responsible for maintaining the database.   
 
Case Report Form Completion 
 
All sites will be required to complete and submit patient case report forms on Biomet’s 
online database Joint Assist (https://www.jointassist.com) in a timely manner.  Forms will 
be monitored for completeness and accuracy.  It is imperative that the investigator answers 
all questions on the case report forms. 
 
 

FINAL 
FINAL 
FINAL 
5 
 
Data Retention and Destruction 
 
All information entered into the Joint Assist Database will be stored indefinitely. Each 
participating investigator will only have the opportunity to view their patient information.  
Other individuals having access to the de-identified patient data outside of the surgeons’ 
site are the Biomet Study Manager and Biomet’s Clinical Data Coordinator who oversees 
the Joint Assist database. It is up to the investigators discretion on whether they give their 
research assistant(s) access to the Joint Assist program.  
 
The investigator will be responsible for retaining, hardcopy, source documents for their 
files.  
 
Treatment 
 
The surgeons will follow preoperative and postoperative routine standards of care for 
patients undergoing total shoulder replacement surgery.  All patients will receive a 
Biomet® Comprehensive® Reverse Shoulder Mini Baseplate and mini stem. 
 
Monitoring 
 
The site will be required to complete study forms by electronic submission, in a timely 
manner to the Biomet database.  Forms will be monitored for completeness and accuracy.  
It is imperative that investigators answer all questions on the case report forms. 
 
Monitoring of protocol deviations, to ensure that the study is being conducted consistent 
with the protocol, and subject rights violations is planned at least annually.  This 
monitoring will be performed by the Clinical Research Coordinator in Korea (Anna Lee). 
 
Data Collection 
 
This is an observational study, and once patients are enrolled and surgeries completed, 
they will be followed-up at: 
 
- 
 0 – 6 weeks, 
- 
6-months,  
- 
1-year and  
- 
3-years. 
 
A. 
Demographic Data 
 
 
The demographic data will be collected at the preoperative visit.  Please see the 
Historical Record in the Case Report Forms for the variables collected. 
 
 
B. 
Operative Data 
 

FINAL 
FINAL 
FINAL 
6 
 
The operative data will be collected during or immediately following surgery.  
Please see the attached Operative Record in the Case Report Forms for the variables 
collected. 
 
C.  
Clinical Data 
 
1. Data Collection Periods and Assessment 
 
a. Preoperative Exam 
b. Operative Report 
c. 0 to 6 weeks post-op   
d. Six Month Follow-Up Exam (-3 months , +3 months) 
e. One Year Follow-Up Exam (-3 Months, +12 Months) 
f. Three Year Follow-Up Exam (±12 Months) 
 
2. Assessment 
a. Modified Constant Assessment 
b. Radiographic Evaluation (including scapular notching) 
c. ASES 
d. VAS  
e. Complications/Lost to Follow-Up 
 
 
Form 
Enrollment 
Pre-op 
Exam 
Surgery 
0 – 6 Wk 
post-op 
6-Months 
post-op 
1-year 
post-op 
3-year 
post-op 
Enrollment & 
Consent 
X 
 
 
 
 
 
 
Pre-op 
Hx/Demographics 
 
X 
 
 
 
 
 
Surgical Form 
 
 
X 
 
 
 
 
Constant Score 
 
X 
 
X 
X 
X 
X 
ASES 
 
X 
 
X 
X 
X 
X 
VAS 
 
X 
 
X 
X 
X 
X 
Radiographic 
Assessment 
 
X 
 
X 
X 
X 
X 
CT 
 
 
 
X 
 
X 
X 
CT Assessment 
 
 
 
X 
 
X 
X 
Adverse Events 
 
 
As Needed 
As Needed 
As Needed 
As Needed 
As Needed 
Lost To Follow-up 
 
 
As Needed 
As Needed 
As Needed 
As Needed 
As Needed 
Protocol Deviation 
As Needed 
As Needed 
As Needed 
As Needed 
As Needed 
As Needed 
As Needed 
 
 
D. 
Radiographic Data 
 
 

FINAL 
FINAL 
FINAL 
7 
 
A true external rotation AP view of the shoulder and an axillary view of the shoulder 
will be taken at the pre-operative, 0 to 6 weeks, 6 months, 1-year and 3-year follow-
up visits.  Radiographs must be de-identified and uploaded as a picture file to the 
Joint Assist database.  Radiographic data will be used to evaluate the presence of 
scapular notching at each follow-up visit.  
 
CT data will also be collected at the first post-operative follow-up, the 1-year follow-
up and the 3-year follow-up.  The protocol for performing the CT can be found in 
Appendix A. 
 
E. 
Complications 
 
It is the responsibility of the investigator to identify and report all complications in 
the Joint Assist Database.  The following definition will be used in this data 
collection: 
 
Complication:  Any untoward medical occurrence in a patient administered a 
medical device and  which does not necessarily have to have a causal relationship 
with this treatment.  A complication can, therefore, be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease 
temporally associated with the use of a device, whether or not  considered related 
to this device. 
 
F. 
Complaints 
 
Complaints and events reportable under FDA’s MedWatch Regulations should also 
be reported to Biomet’s Regulatory Department (800-348-9500 ext. 1305). 
 
Definitions 
 
Inferior Notching:  An erosion of the scapular neck in proximity to the glenoid prosthesis.  
Classified by the Nerot grading system. 
 
Anterior Notching:  Any glenoid radiolucency disrupting the normal contour of the lateral 
bone adjacent to the glenosphere anteriorly. 
 
Posterior Notching:  Any glenoid radiolucency disrupting the normal contour of the 
lateral bone adjacent to the glenosphere posteriorly. 
 
Scapular Neck Angle (SNA):  The angle subtended by the intersection of line AB and line 
BC.  Point C is located 1 cm medial to the most inferior and lateral bone of the inferior 
glenoid rim. 

FINAL 
FINAL 
FINAL 
8 
 
 
 
Annual Reports 
 
The study sponsor will present an annual report to the study investigators that will include 
a summary of the clinical data.   
 
 
Analysis / Reports 
 
Data collected as part of this study will be used to evaluate: 
- 
Survivorship (including glenoid loosening) 
- 
Adverse events (including dislocation) 
- 
Constant Scores 
- 
Radiographic results for both plain radiographs and CT images  (including 
scapular notching) 
- 
Analysis may also include 3D reconstructions of CT scans and further analysis of 
implant sizing 
 
Patient Withdrawal 
 
It is recognized that the subject’s participation in this trial is entirely voluntary, and that she/he 
may refuse to participate and may withdraw from participation at any time without jeopardy to 
any future medical care.  It is also recognized that the investigator, at his/her discretion, may 
withdraw a subject from this study based upon his/her professional judgment.  In event of subject 
withdrawal, applicable local procedures should be followed 
 
Risk Analysis 
 
The following possible adverse effects are associated with shoulder replacement surgery as 
stated in the package insert for this device. 

FINAL 
FINAL 
FINAL 
9 
 
 
WARNINGS 
 
Improper selection, placement, positioning, alignment and fixation of the implant 
components may result in unusual stress conditions which may lead to subsequent 
reduction in the service life of the prosthetic components. The use of a reverse 
shoulder prosthesis in patients with a deficient rotator cuff could increase the risk 
of component loosening due to non-anatomic loading conditions. Malalignment of 
the components or inaccurate implantation can lead to excessive wear and/or 
failure of the implant or procedure. Inadequate preclosure cleaning (removal of 
surgical debris) can lead to excessive wear. Use clean gloves when handling 
implants. Laboratory testing indicates that implants subjected to body fluids, 
surgical debris or fatty tissue have lower adhesion strength to cement than implants 
handled with clean gloves. Improper preoperative or intra-operative implant 
handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, 
fatigue fracture and/or excessive wear. Do not modify implants. The surgeon is to be 
thoroughly familiar with the implants and instruments, prior to performing surgery. 
 
1.  Humeral and glenosphere components should be used only when there is 
good quality bone. 
2.   Disassociations of modular components have been reported. Failure to 
properly align and completely seat the components together can lead to 
disassociation. Thoroughly clean and  dry tapers prior to attachment of modular 
components to avoid crevice corrosion and  improper seating. All additional 
locking screws must be adequately tightened. 
3.   Care is to be taken to assure complete support of all parts of the device 
embedded in bone cement to prevent stress concentrations that may lead to 
failure of the procedure.  Complete preclosure cleaning and removal of bone 
cement debris, metallic debris and  
other surgical debris at the implant site is 
critical to minimize wear of the implant articular surfaces. Implant fracture due 
to cement failure has been reported.  
 
Biomet® joint replacement prostheses provide the surgeon with a means of 
reducing pain and restoring function for many patients. While these devices are 
generally successful in attaining these goals, they cannot be expected to withstand 
the activity levels and loads of normal healthy bone and joint tissue.  
 
Accepted practices in postoperative care are important. Failure of the patient to 
follow postoperative care instructions involving rehabilitation can compromise the 
success of the procedure. The patient is to be advised of the limitations of the 
reconstruction and the need for protection of the implants from full load bearing 
until adequate fixation and healing have occurred. Excessive activity, trauma and 
excessive weight bearing have been implicated with premature failure of the 
implant by loosening, fracture, and/or wear. Loosening of the implants can result in 
increased production of wear particles, as well as accelerate damage to bone, 
making successful revision surgery more difficult. The patient is to be made aware 

FINAL 
FINAL 
FINAL 
10 
 
and warned of general surgical risks, possible adverse effects as listed, and to follow 
the instructions of the treating physician, including follow-up visits. 
 
PRECAUTIONS 
 
Patient selection factors to be considered include: 1) need to obtain pain relief and 
improve function, 2) ability and willingness of the patient to follow instructions, 
including control of weight and activity levels, 3) a good nutritional state of the 
patient and 4) the patient must have reached full skeletal maturity, and the patient 
must have a functional deltoid muscle. 
 
Specialized instruments are designed for Biomet® joint replacement systems to aid 
in the accurate implantation of the prosthetic components. The use of instruments 
or implant components from other systems can result in inaccurate fit, incorrect 
sizing, excessive wear and device failure. Intraoperative fracture or breaking of 
instruments has been reported. Surgical instruments are subject to wear with 
normal usage. Instruments that have experienced extensive use or excessive force 
are susceptible to fracture. Surgical instruments should only be used for their 
intended purpose. Biomet recommends that all instruments be regularly inspected 
for wear and disfigurement. 
 
Do not reuse implants. While an implant may appear undamaged, previous stress 
may have created imperfections that would reduce the service life of the implant. Do 
not treat patients with implants that have been, even momentarily, placed in a 
different patient. 
 
POSSIBLE ADVERSE EFFECTS 
 
1. Material sensitivity reactions. Implantation of foreign material in tissues can 
result in  histological reactions involving various sizes of macrophages and 
fibroblasts. The clinical  significance of this effect is uncertain, as similar changes 
may occur as a precursor to or during the healing process. Particulate wear 
debris and discoloration from metallic and polyethylene components of joint 
implants may be present in adjacent tissue or fluid. It has  been reported that 
wear debris may initiate a cellular response resulting in osteolysis, or osteolysis 
may be a result of loosening of the implant. 
2.  Early or late postoperative infection and allergic reaction. 
3.  Intraoperative bone perforation or fracture may occur, particularly in the 
presence of poor bone stock caused by osteoporosis, bone defects from 
previous surgery, bone resorption,  
or while inserting the device. 
4.  Loosening or migration of the implants can occur due to loss of fixation, 
trauma,  malalignment, bone resorption and/or excessive activity. 
5.  If glenoid component is not securely fixed, micromotion can lead to 
peripheral screw failure. 
6.  Periarticular calcification or ossification, with or without impediment of joint 
mobility. 

FINAL 
FINAL 
FINAL 
11 
 
7.  Inadequate range of motion due to improper selection or positioning of 
components, lack of rotator cuff, and inadequate function of the deltoid. 
8.  Undesirable shortening or lengthening of limb. 
9.  Dislocation and subluxation due to inadequate fixation and improper 
positioning. Muscle and fibrous tissue laxity or excessive activity can also 
contribute to these conditions. 
10. Fatigue fracture of component can occur as a result of loss of fixation, 
strenuous activity, malalignment, trauma, non-union, or excessive weight. 
11. Fretting and crevice corrosion can occur at interfaces between components. 
12. Wear and/or deformation of articulating surfaces. 
13. Intraoperative or postoperative bone fracture and/or postoperative pain. 
14. Scapular notching and bone erosion has been reported with the use of 
reverse shoulder implants. Scapular notching may lead to early failure of 
glenoid fixation. 
 
Reports 
 
The sponsor will present an annual report to the investigators that will include a 
summary of the clinical data.  The report will contain the results of: 
 
- 
Survivorship 
- 
Adverse Events 
- 
Modified Constant Score 
- 
Incidence of scapular notching  
- 
List of reported complications.   
 
Patient follow-up will be analyzed throughout the data collection according to the 
following definition and equations: 
 
 
Lost To Follow-Up: 
 
1. Death 
2. Revision 
3. Consent Rescinded 
 
 
Percentage Follow-up =           # Patients with Follow-Up______ x 100                                 
                                       (Theoretically due – Lost To Follow-Up) 
 
 
 
Percentage Accounted for = (# with Follow-Up + Lost To Follow-Up) x 100 
 
 
 
                         Theoretically due 
 
At the end of the data collection, a final report will be compiled that will summarize 
all data collected, complications reported, and general findings. 
 
 

FINAL 
FINAL 
FINAL 
12 
 
Appendix A 
 
CT Protocol 
 
 
General Scan Requirements 
 
Computerized Tomography (CT) is required for Signature Guide production. 
Scanners must have ability to scan 0.5mm or 0.625mm thickness. 
 
 
 
 
Patient Position 
 
Patient is positioned on the scanning couch in the supine position with hand 
of side of interest PALM “up” in anatomical position. Sandbag or other 
immobilizing device should be used to maintain patient position. 
 
 
 
 
Scan Parameters 
 
AXIAL images are acquired from above the acromion process to below the 
inferior angle of the scapula. Slices are positioned perpendicular to the 
glenoid fossa or parallel to the scapular spine. The  entire scapula and 
adjacent humerus must be included in the FOV. Use the smallest FOV 
possible to acquire all boney anatomy of the scapula and adjacent humerus. 
 
Axial Helical or contiguous slices .625mm or less 
FOV 250mm or smallest to include all boney anatomy of scapula AND 
adjacent humerus anatomy (see figure 2) 
Soft tissue algorithm 
512 x 512 matrix 
120 kVp 

),1$/
),1$/
),1$/







Anterior View 
Posterior View 











Figure 1 – All bony anatomy of the scapula to be included with adjacent humeral head and shaft 

FINAL 
FINAL 
FINAL 
14 
 
 
 
Figure 2  FOV to include all of boney anatomy of scapula and adjacent humerus below the level of the inferior 
scapular angle 

FINAL 
FINAL 
FINAL 
15 
 
 
 
Figure 3 Axial CT Images from above acromion process to below inferior angle of scapula 

 
 
Page 16 of 17 
 
Only axial images are required. No image reformats are needed. Images should be 
transmitted in uncompressed DICOM format via the Biomet Virtual PACS (MedWeb) in the 
original acquired thickness. 
 
 
 
 
 
 
Frequently asked questions: 
 
Does the position of the hand make a difference?  Yes. The hand should be positioned palm up to allow the best 
visualization of anatomy of interest. 
 
Can I scan with a thicker slice and reformat to 0.5mm or 0.625mm?  No. Images must be acquired at a thickness of 
0.625mm or less. 
 
Will reformats in the coronal and Sagittal planes help? No. And the transmission of these additional images may 
hinder the transmission of the required image set. 
 
How will I know if my images are good?  If there is a need to rescan a patient you will be contacted by a 
Biomet Signature representative. 
 
How do I evaluate my images to know they are adequate?   Confirm the below: 
 
1.   There is no motion evident 
 
2.   All bony scapula anatomy and adjacent humeral anatomy are present 
 
3.   The images are acquired with the soft tissue algorithm 
 
4.   The slice thickness is not greater than 0.625mm 
 
5.   The FOV is not greater than 250mm 
 
Who can I call if I have other questions?  Clinical Research Coordinator in Korea:  Anna Lee (82 70 7123 6337) 
 
 

 
 
Page 17 of 17 
 
 
Clinical Protocol Change History 
 
 
From 
Version 
To Version 
Description of Change 
Page 
number 
Study Manager 
approval 
Director 
Approval 
 
 
Initial version