VR 4 BR: Effects of Virtual Reality on Women Undergoing Mastectomy and Breast Reconstruction, A Pilot Study
Phase: NA
Conditions: Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
Sponsor: Cedars-Sinai Medical Center

Amendment 1.1 – December 5, 2018  
1 
 
 
 
 
 
Effects of Virtual Reality on  
Women Undergoing Breast Reconstruction 
VR 4 BR 
A Pilot Study 
 
 
Principal Investigator:  
Alice Chung, MD 
 
 
 
 
Cedars-Sinai Medical Center 
 
 
 
 
8700 Beverly Blvd, Los Angeles, CA 90048 
 
  
Sub-Investigator(s) 
Department/Division 
Brennan Spiegel, MD 
Health Services Research  
Brandon Birckhead, MD 
Health Services Research 
Parisa Mirzadehgan, MPH 
SOCCI CRO 
Armando Giuliano, MD 
Surgery/Breast Center  
Farin Amersi, MD 
Surgery/Breast Center
Catherine Dang, MD 
Surgery/Breast Center 
Scott Karlan, MD 
Surgery/Breast Center
Galen Cook-Wiens 
Statistician  
Edward Phillips, MD 
Surgery/Breast Center 
 
 
 
 
 
 
 
 
 
 
 

Amendment 1.1 – December 5, 2018  
2 
 
 
 
 
STUDY SCHEMA 
 
   
Intervention  
Screening and Enrollment
Primary endpoint: Opioid use 
Baseline Procedures
Post-op Assessment 

Amendment 1.1 – December 5, 2018  
3 
 
 
 
BACKGROUND AND RATIONALE 
1.1 
Disease Background 
 
Pain management is a crucial aspect of study participant-centered care. However, the current 
increase in prescription opioid misuse and overdose fatalities is evident to the dangers of these 
medications.  According to the 2016 National Survey on Drug Use and Health, an estimated 11.8 
million people misused opioids in the previous year [1].  Factors such as diagnosis distress, 
invasive procedures, as well as pain related to therapies can make cancer study participants 
undergoing therapies vulnerable to opioid misuse [2-4].  Postoperative prescription opioid misuse 
is well-documented in the literature.  About 6% opioid-naive study participants undergoing 
noncancer procedures develop new persistent opioid use [5].  For study participants with cancer 
undergoing curative-intent surgery, the risk of new persistent opioid use is 10.4% [6]. 
 
As for many types of surgery, opioids are used for pain control after mastectomy and breast 
reconstruction. Marcusa et al. utilized health benefits claims to identify 4,113 women who 
underwent mastectomy for breast cancer and immediate breast reconstruction between 2010 and 
2014. All study participants were opioid-naïve. Based on the pharmacy claims data after breast 
reconstruction, 90 percent of study participants filled an opioid prescription.  Ten percent of these 
women continued to fill an opioid prescription three months later. For women diagnosed with 
anxiety and those who experienced some type of complication (such as infection) prolonged 
opioid use was more common [7].   
 
 
Most opioid prescribing guidelines focus on study participants with chronic pain, rather than 
postoperative pain. To our knowledge, there is no guidelines for opioids prescription following 
mastectomy and reconstruction procedures.  
 
 
Rising rates of opioids prescription contribute to the opioid epidemic.  The threat of dependence 
and prolonged use of opioids prescribed after surgery cannot be overemphasized.  Alternative, 
non-pharmacological interventions to control pain after surgery seem to be the best approach to 
address this problem.  Virtual Reality (VR) can be a viable approach.  
 
 
VR provides immersive, realistic, three-dimensional experiences that “transport” users to novel 
environments. Thus, it has the potential to alleviate negative aspects of care by providing multi-
sensory information and allowing study participants to “escape” to pleasant locations and realities 
when they are most distressed.  VR offers an ability to temporarily alter the way study participants 
experience their environment, facilitating distraction from symptom triggers, increasing sense of 
control, and providing a safe coping mechanism.  By providing an alternative to excess opioid use 
for pain, VR may not only ameliorate acute symptoms, but also diminish opioid-related adverse 
effects such as overdose and opioid use disorder, and reduce hospital length of stay.  
 
Feasibility of VR interventions in a medical setting has been documented in the literature [8].  To 
our knowledge, effects of VR in controlling pain and study participant’s satisfaction for women 
undergoing mastectomy followed by implant-based reconstruction has not been studied.   
 
2.0 
STUDY OBJECTIVES 
Primary Objectives 
 
 

Amendment 1.1 – December 5, 2018  
4 
2.0.2 
To estimate the effect of utilizing VR  on reducing opioid use in study participants 
undergoing mastectomy with implant-based reconstruction compared to the 
control group   
2.1 
Secondary Objectives  
2.1.1 
To evaluate the effects of VR upon:  
a) Pain scores 
b) Study participant satisfaction 
c)  Length of stay  
 
2.2 
Endpoints 
 
 
Primary Efficacy Endpoint 
 
Opioid use 
 
 
Secondary Efficacy Endpoints 
 
Pain score 
 
Patient satisfaction 
 
Length of stay   
 
 
3.0 
STUDY DESIGN 
We will conduct a pilot study of VR non-opioid management for women undergoing mastectomy 
and implant-based reconstruction. Study participants will receive specialized VR interventions, 
administered via VR headsets, to manage pain.  
Historical control patients of the study investigators, who have undergone mastectomy and 
implant-based reconstruction between October 2008 to October 2018, will be identified by the 
Cancer Registry, according to the study eligibility criteria, and matched based on the following 
criteria: 
 
Age and gender  
 
Prophylactic or cancer  
 
Pre- or post-pectoral approach  
 
Sentinel biopsy, axillary dissection, or no nodal surgery  
 
Use of Paravertebral Block Analgesia (PVB) 
 
Neoadjuvant therapy or not 
The matching will be done by the study statistician.  Prior to sending the log to the statistician, the 
Cancer Registry database will be deidentified by the study staff and coded to ensure patient 
confidentiality. This portion of the study this is a retrospective data analysis and a waiver of 
consent and HIPAA authorization will be requested to review and collect data from these patients’ 
medical records. 
 
 
 
 
 
 

Amendment 1.1 – December 5, 2018  
5 
4.0 
PATIENT ELIGIBILITY  
4.1 
Inclusion Criteria  
4.1.1 
Age ≥ 18 years  
4.1.2 
Women who plan to undergo mastectomy and implant-based reconstruction  
4.1.3 
Written informed consent obtained from subject and ability for subject to comply 
with the requirements of the study. 
 
 
4.1.4 
Able to read and comprehend English  
4.2 
Exclusion Criteria 
4.2.1 Current diagnosis of epilepsy, dementia, or other neurologic disease that may 
prevent use of VR headset and software 
 
4.2.2 Sensitivity to flashing light  
 
 
4.2.3 Diagnosis of motion sickness  
 
4.2.4 Pregnancy or a medical condition where the study participant is prone to frequent 
nausea or dizziness  
 
4.2.5 Current or recent (less than 6 months) use of opioids 
 
4.2.6 Individuals with psychiatric disorders, including those with delirium or other 
disorders that may involve hallucinations or psychosis 
 
 
5.0 
TREATMENT PLAN 
5.1 
Treatment Dosage and Administration 
 
5.1.1 Pre-op visit: 
Eligible women will sign the study consent form at one of their pre-operative appointments.  
During this visit, a study staff member will explain the use of the VR goggle set by watching a 
short VR experience of swimming with dolphins, lasting approximately 2 minutes.  The study 
participant and/or a member of their family will be shown how to use the device and how to 
recharge the battery, if needed. At this time, the patient will be offered the opportunity to test a VR 
set. Study participants will be advised that standing puts them at risk for a fall, and that they 
should remain seated for each VR intervention.  An interval of 15 minutes is suggested for first-
time use, but study participants will be allowed to continue as long as they are not experiencing 
any discomfort or side effects (dizziness, motion sickness, etc.). 
 
We will keep a log of reasons for eligible patients who decline study participation. 
 
 
5.1.2 After surgery: 
After surgery, and once alert, the study participant can start using VR.  The participants will be 
instructed to use VR the first time they feel pain and prior to requesting/taking opioids.  They will 
be instructed to repeat that at least within 3 hours of first usage, the morning after the operation 
and once before discharge and any time they feel pain.  Study participants will be instructed to 

Amendment 1.1 – December 5, 2018  
6 
use the VR every time they feel pain and before asking for a pain medication.  They can take pain 
medications, if they choose to do so.  
 
Compliance to the protocol will be monitored using software for the VR modules and remote data 
uploads of activity. Additionally, study participants will be asked to log the time and duration of VR 
usage (appendix 2). 
 
Pain ratings and pain medication usage history throughout hospitalization will be retrieved from 
the EHR by study staff.  Pain rating scales and collection of medications will be done as per 
standard of care, and this information will then be pulled from the medical records.   
 
 
5.1.3 Post-op visit: 
Patient Semi-Structured Interview: 
At one of their post-op visits at the Breast Center, using the provided patient interview script on 
Appendix 1, patients will be asked questions regarding their experience with VR.  Responses will 
be written down by the study staff.     
 
 
5.2 
Use of Opioids 
In order to capture medication use related to their injury, including the use of opioids, we will link 
patient electronic health record (EHR) data to the other data sources using Medical Record 
Numbers and date of birth. We will collect opioids information using. CSLINK.  Prescribed opioid 
medications include: codeine, dihydrocodeine, morphine, hydromorphone, oxymorphone, 
tapentadol, buprenorphine, methadone, oxycodone, fentanyl, remifentanil, and hydrocodone. 
Tramadol usage will also be included.  We will convert all opioid doses into a single metric using 
morphine milligram equivalents (MME). 
 
 
 
5.3 
Risks 
Women using the virtual reality intervention may experience side effects common to users of VR 
and individuals who view 3D video, including motion sickness, dizziness, eye strain, headaches, 
or other visual abnormalities. If a study participant experiences these symptoms, she will be 
asked to stop using the VR software for 15 minutes and will be allowed to continue if she wishes 
to proceed. A small number of patients (up to 0.025%) may experience seizures or severe 
symptoms (e.g., disorientation, nausea, or drowsiness) upon viewing the virtual reality 
experience. Seizures from flashing light are more common in children and epileptic patients (who 
are excluded). To minimize this concern further, we have not incorporated flashing lights into the 
VR experiences. Some study participants may find the VR goggles uncomfortable to wear or 
confining. To date, patients with claustrophobia have not reported discomfort using VR goggles, 
as they are often used in treatment of that condition. Nevertheless, individuals previously 
diagnosed with claustrophobia should discontinue use if they feel uncomfortable. A trained study 
staff member will be available during initial use to ensure safety. Study participants who use the 
VR headset over several days are instructed to use it for a maximum of 30 minutes at a time. In 
pilot testing, patients have not reported any adverse effects from extended use of VR hardware. 
Subjects may feel uncomfortable when answering survey and interview questions. If subjects are 
uncomfortable answering any survey question, they may skip it. The survey will be labeled with a 
unique study number so that only the research team can identify subjects. 
 
5.4 
Duration of Study Participation  
 
The study duration for each study participant will start prior to surgery and will end after their post-
op visit once the interview has been conducted.  
 

Amendment 1.1 – December 5, 2018  
7 
5.5 
Subject Replacement 
Subjects who withdraw from the study treatment prior to starting study intervention will be 
replaced.   
 
6.0 
STUDY PROCEDURES 
 
6.1 
Screening/Baseline Procedures 
6.1.1 Informed Consent 
Eligible subjects will be identified by the investigators and research staff according to the 
eligibility criteria.  Subjects will be asked to sign and date the Informed Consent and 
HIPAA Authorization form after receiving a complete explanation of the research study 
including risks, benefits, and alternatives to participation.  Eligible subject must have the 
ability to understand and the willingness to sign a written informed consent document. 
6.1.2 Demographics 
Name, medical record number, age, gender, race/ethnicity obtained from medical 
records 
6.1.3 Review subject eligibility criteria 
6.2 
Procedures During Treatment 
Pain scores will be recorded using pain scores reported to the care providers and entered 
in the EHR. 
 
Opioid use will be collected via information recorded in the EHR (CS-Link). 
Study participant will be approached at their post-op visit to complete study 
questionnaires as well as the study interview. 
 
6.3 
Removal of Subjects from Study 
Patients can be taken off the study treatment and/or study at any time at their own 
request, or they may be withdrawn at the discretion of the investigator for safety, 
behavioral or administrative reasons. The reason(s) for discontinuation will be 
documented and may include: 
5.5.1 
Patient voluntarily withdraws (follow-up permitted);  
5.5.2 
Patient withdraws consent (termination of treatment and follow-up); 
5.5.3 
Patient is unable to comply with protocol requirements; 
55.5.5 Patient experiences toxicity that makes continuation in the protocol unsafe; 
5.5.6 
Treating physician determines continuation on the study would not be in the 
patient’s best interest; 
 
7.0 
Virtual Reality   
7.1 
We will use a Samsung Gear VR goggle set, fitted with a Samsung Galaxy phone that 
delivers VR images and sound.  Samsung Gear was selected because it is commercially 
available, widely used, relatively inexpensive, has minimal visual latency, and offers a generally 
positive patient experience based on our previous research. [8]   

Amendment 1.1 – December 5, 2018  
8 
 
We will use the appliedVR app to offer >30 therapeutic VR experiences through the headsets. 
Our team has worked with appliedVR to curate experiences that are acceptable to a wide range 
of patients. The app includes a menu of visualizations, each mapped to a therapeutic benefit (e.g. 
pain reduction, anxiety reduction, mindful meditation).  
 
The app includes “Pain RelieVR”, a 15-minute VR experience specifically designed to treat pain 
in patients with limited mobility. Pain RelieVR is an immersive, 360-degree game experience that 
takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving 
objects by maneuvering their head towards the targets. This engaging, medium-intensity activity 
is free of interruption, offering the user a distracting experience designed to reduce the perception 
of pain. Pain RelieVR is a non-violent and non-competitive game that incorporates motivational 
music and features positively reinforcing sounds, animation and direct messages to patients. 
Forward- facing action allows patients with limited mobility to engage without having to turn 
backwards or contort into potentially uncomfortable positions. 
The app also includes “Anxiety RelieVR,” an interactive, meditative landscape along a peaceful 
shoreline. In contrast to Pain RelieVR, which acts through distraction therapy, Anxiety RelieVR 
employs mindful meditation to help manage the affective component of pain. These cornerstone 
experiences are supported by a wide range of additional therapeutic journeys, including an 
Iceland flyover in a helicopter, an undersea experience, and a variety of nature-related 
experiences, among many others. 
 
Another option is “EaseVR” which is a new meditation VR experience that is currently being used 
in several pain studies within Cedars-Sinai and beyond. During the program the patient can be in 
8 different environments while a narrator who is an expert in meditation walks through the 
experience. The patient will have a microphone to deep breath with the meditation program.  
 
Patients can pick and choose which visualizations to watch based on their own preferences. In 
clinical testing, we asked patents to use the headset at least thrice daily, for 15 minutes per 
treatment period, and to also use as needed for breakthrough pain between treatments. The 
appliedVR software allows our team to monitor adherence with the therapy, including the 
visualizations selected by the user, the amount of exposure time, and the time of day the 
visualization was viewed. 
 
Using Samsung Gear goggles, participants will be shown a short VR experience of swimming 
with dolphins, lasting approximately 2 minutes. During your pre-op visit, a study staff member will 
show the participants how to use the VR goggles and connected smartphone and answer any 
questions about them. 
 
They will be asked to watch VR only once after they wake up after surgery, and any time they feel 
pain. We recommend taking short, 5-10-minute breaks after 30 minutes of use, but they may 
continue afterward. This experience is an addition to usual care in the hospital and will not impact 
any additional care the participants receive at CSMC.  
 
We will also obtain pain ratings, participants’ use of pain medication while recovering from the 
surgery, and any physical symptoms they report to the nurse throughout your stay. Recording all 
of this information is standard of care. It is not being done for research. We will review medical 
records to obtain this type of information.   
 
 
 
 
 
 
 

Amendment 1.1 – December 5, 2018  
9 
8.0 
STATISTICAL CONSIDERATIONS 
8.1 
Sample Size 
 
This is an exploratory pilot study to estimate the effect of VR on opioid use during the 
stay. We will enroll 20 eligible patients to this study.  
We will include data from 20 
patients for the historical control portion of the study matched 1 to 1 on age, surgery type, 
use of neoadjuvant therapy, and use of paravertebral block analgesia. Assuming a 
standard deviation of 1, a sample size of 20 matched pairs would produce a confidence 
interval with a distance from the mean to the limits that is equal to 0.468 for the difference 
in requested pill count. 
9.2 
Data Analyses/Study Endpoints 
 
 
Quantitative data will be expressed as mean ± standard type or median with interquartile 
range, and categorical variables as counts and frequencies.  We will use complete case 
analysis to manage missing data. All statistical analyses will involve the use of Excel. 
 
Descriptive statistics will be used to summarize pain scores and opioid use in the 
intervention and the historic control group. Average number of opioid pills requested will 
be compared between the study cohort and the historic control group. A paired t test will 
be used to compare the difference in average pill count between the two groups based 
on the matched pairs with historic controls. Confidence intervals for the number of pills 
and the secondary endpoints of reported pain scores, satisfaction, and length of stay will 
be calculated in the study cohort and for the historic controls. 
 
9.0 
STUDY MANAGEMENT 
9.1 
Conflict of Interest 
Any reportable conflict of interest will be disclosed to the local IRB and will be outlined in 
the Informed Consent Form. 
9.2 
Institutional Review Board (IRB) Approval and Consent  
It is expected that the IRB will have the proper representation and function in accordance 
with federally mandated regulations. The IRB should approve the consent form and 
protocol. 
 
In obtaining and documenting informed consent, the investigator should comply with the 
applicable regulatory requirement(s), and should adhere to Good Clinical Practice (GCP) 
and to ethical principles that have their origin in the Declaration of Helsinki. 
 
 
Before recruitment and enrollment onto this study, the patient will be given a full 
explanation of the study and will be given the opportunity to review the consent form. 
Each consent form must include all the relevant elements currently required by the FDA 
Regulations and local or state regulations. Once this essential information has been 
provided to the patient and the investigator is assured that the patient understands the 
implications of participating in the study, the patient will be asked to give consent to 
participate in the study by signing an IRB-approved consent form. 
 
Prior to a patient’s participation in the trial, the written informed consent form should be 
signed and personally dated by the patient and by the person who conducted the 
informed consent discussion. 

Amendment 1.1 – December 5, 2018  
10 
9.3 
Registration Procedures 
 
All subjects that sign informed consent will be assigned a subject number sequentially by 
their date of consent.  Those subjects that do not pass the screening phase will be listed 
as screen failures on the master list of consented subjects.  Eligible subjects, as 
determined by screening procedures and verified by a treating investigator, will be 
registered on study at Cedars Sinai Medical Center by the Study Coordinator.   
 
Assignment of Subject ID: The study team will track all subjects who sign consent on a 
subject screening/enrollment log using a unique screening ID (S001, S002, etc.). 
Subjects found to be ineligible will be recorded as screen failures.  
 
 
 
 
Eligibility Verification 
 
Prior to registration, all subjects must undergo eligibility verification by the investigators.  
The following documents will be completed and provided for review: 
 
 
Registration form (or equivalent) 
 
Copy of applicable source documents 
 
Eligibility checklist (signed by investigator) 
 
Signed patient consent form and Subject’s Bill of Rights 
 
HIPAA authorization form 
 
 
 
Oversight by the principal investigator is required throughout the entire registration process 
 
 
 
9.4 
Data Management and Quality Control and Reporting 
Data will be entered into a HIPAA-compliant database. The Study Staff will be 
responsible for data processing, in accordance with procedural documentation. Data 
collected from medical record, such as opioid prescriptions and physician history, will 
reside on secure CSMC servers and an ID will be assigned to each individual in order to 
abstract PHI and the medical record number. Each dataset will utilize different unique 
ID's and a list linking each unique ID to each participant will be stored internally on the 
secured CSMC network. The linking list allows a researcher with access to the secured 
files to merge all data using statistical software, while maintaining data confidentiality. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Amendment 1.1 – December 5, 2018  
11 
 
 
 
 
 
 
 
10.0 
REFERENCES 
  
 
1. 
Ahrnsbrak , R., et al., Key Substance Use and Mental Health Indicators in the United 
States: Results from the 2016 National Survey on Drug Use and Health. 2016. 
2. 
Portenoy, R.K. and E. Ahmed, Cancer Pain Syndromes. Hematol Oncol Clin North Am, 
2018. 32(3): p. 371-386. 
3. 
Tan, P.D., J.S. Barclay, and L.J. Blackhall, Do Palliative Care Clinics Screen for 
Substance Abuse and Diversion? Results of a National Survey. J Palliat Med, 2015. 
18(9): p. 752-7. 
4. 
Swarm, R.A., et al., Adult cancer pain. J Natl Compr Canc Netw, 2013. 11(8): p. 992-
1022. 
5. 
Soneji, N., et al., Risks of Developing Persistent Opioid Use After Major Surgery. JAMA 
Surg, 2016. 151(11): p. 1083-1084. 
6. 
Lee, J.S., et al., New Persistent Opioid Use Among Patients With Cancer After Curative-
Intent Surgery. J Clin Oncol, 2017. 35(36): p. 4042-4049. 
7. 
Marcusa, D.P., et al., Prescription Opioid Use among Opioid-Naive Women Undergoing 
Immediate Breast Reconstruction. Plast Reconstr Surg, 2017. 140(6): p. 1081-1090. 
8. 
Mosadeghi, S., et al., Feasibility of an Immersive Virtual Reality Intervention for 
Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health, 2016. 3(2): p. 
e28. 
 

Amendment 1.1 – December 5, 2018  
12 
APPENDIX 1 
 
Qualitative Interview 
 
Patient Interview Script 
 
We want to thank you for your participation in the study and for agreeing to talk with us today. 
This interview will take approximately 10-15 minutes, and we will ask you several open-ended 
questions about your thoughts and feelings about wearing the Virtual Reality device and 
“participating” in the experiences. There are no ‘right’ or ‘wrong’ answers to any of these 
questions: we want to hear about your experience and listen to your opinion, in your own words. 
 
 
General “Think Aloud” Probe 
When you think about your experience participating in the Virtual Reality study, what is the first 
thing that comes to your mind? 
 
 
 
 
Participating in the Intervention: 
Would you like to participate in a study like this one again? Why? 
 
How did participating in this study make you feel? 
(PROBES: distracted, happy, confused, dizzy, anxious, at ease, etc.) 
 
 
 
 
The VR Device: 
If a friend or family member asked you about the device, what would you tell them about it?  
 
 
How comfortable were you wearing the device? 
 
 
Did you have any concerns about the device while you were using it? If so, what were they? 
 
 
Did you have any questions about the device while you were using it? If so, what were they?  
(Researcher should record if patient asked questions while using it) 
 
 
 
Do you have any thoughts on how the device can be improved? 
 
 
 
VR Experiences: 
From what you watched, which did you like the most? Why? 
 
 
From what you watched, which did you like the least? Why?  
 
 

Amendment 1.1 – December 5, 2018  
13 
What was your favorite part about watching the ‘experiences’? 
 
 
What was your least favorite part about watching the ‘experiences’? 
 
 
What did you think about the duration of the ‘experiences’? Were they too long? Too short? 
 
 
What would be your ideal ‘experience’ duration? (e.g. how many minutes long would you want 
them to be) 
 
 
If at all, how do you think the ‘experiences’ can be improved?  
 
 
What would you like to see in additional ‘experiences’? 
 
 
 
Would you recommend the Virtual Reality to your family and friends? 
 
 
Perceived Effects of Participation: 
[IF ANXIETY IS A CONCERN:] Do you think that wearing the device affected your anxiety level? 
[IF YES:] How so? 
 
 
 
 
Do you think that wearing the device affected your pain? [IF YES:] How so? 
 
 
 
These are all the questions we have for you today. Is there anything we didn’t mention that you 
would like to discuss? 
 
 
 
 
 
Thank you again for your participation in this study, and please feel free to contact our research 
coordinator if you have anything else you would like to discuss with us about this project. 
 
 
 
 
 
 
 
 
 
 
 
 
 

Amendment 1.1 – December 5, 2018  
14 
APPENDIX 2 
 
 
 
 
 
VR Experience Tracking Log 
How many 
times did you 
watch 
Virtual 
Reality 
 
None 
Once  
Twice 
Three 
times 
Four 
times  
More 
than 
four 
times 
DATE
 
  
  
  
  
  
  
 
  
  
  
  
  
  
 
  
  
  
  
  
