Feasibility of a Positive Affect Skills Intervention for Reducing Racial Disparities in Pain Management
Phase: NA
Conditions: Geriatric, Chronic Pain
Sponsor: Weill Medical College of Cornell University

Study Title: Positive Affect as a Source of Resilience for Adults in Chronic Pain 
NCT: NCT04869345 
Document Date: November 10, 2022 
List of Amendments (Approval Dates): 
November 10, 2022 – Administrative demographic file correction 
November 9, 2022 – Study team changes 
August 5, 2022 – Study team changes 
July 6, 2022 – Study team changes 
April 1, 2022 – Continuing Review with study team changes 
October 22, 2021 – Increased number permissible to screen and study team changes 
July 16, 2021 – added fibromyalgia screening tool, recruitment adaptations, study team changes 
May 3, 2021 – Study team changes 
April 9, 2021 – Initial Approval  

Page # i 
 
 
 
 
Table of Contents 
LIST OF ABBREVIATIONS ......................................................................................................... III 
1. PROTOCOL SUMMARY ......................................................................................................... 1 
1.1 Study Objectives ....................................................................................................................... 2 
1.1.1 Objectives 
2 
1.1.2 Hypotheses / Research Questions 
2 
2. BACKGROUND AND SIGNIFICANCE ....................................................................................... 2 
3. STUDY DESIGN AND METHODS ............................................................................................ 3 
4. STUDY DESIGN ..................................................................................................................... 6 
4.1 Study Population ...................................................................................................................... 6 
4.2 Inclusion Criteria ...................................................................................................................... 6 
4.3 Exclusion Criteria ...................................................................................................................... 6 
4.4 Strategies for Recruitment and Retention ............................................................................... 6 
5. REGISTRATION PROCEDURES ............................................................................................... 7 
5.1 Subject Registration (WCM only) ............................................................................................. 7 
5.2 Subject Registration (Sub-sites) ............................................................................................... 7 
6. STUDY PROCEDURES ............................................................................................................ 8 
6.1 Schedule of Assessments ......................................................................................................... 8 
7. DATA REPORTING / REGULATORY CONSIDERATIONS ........................................................... 8 
7.1 Data Collection ......................................................................................................................... 8 
7.1.1 REDCap 
8 
7.2 Regulatory Considerations ....................................................................................................... 8 
7.2.1 Institutional Review Board/Ethics Committee Approval 
8 
7.2.2 Ethical Conduct of the Study 
9 
7.2.3 Informed Consent 
9 
7.2.4 Compliance with Trial Registration and Results Posting Requirements 
10 
7.2.5 Record Retention 
10 
8. STATISTICAL CONSIDERATIONS .......................................................................................... 10 

Protocol #20-06022291 
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Confidentiality Statement 
 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or institutional 
review boards. The contents of this document shall not be disclosed to others without written 
authorization from WCM. 
 
 
 
 
 
 
 
 
 
 
Weill Cornell Medicine 
 
Institution Name 
 
 
 
 
 
 
 
 
 
 
M. Carrington Reid, MD, PhD
 June 29, 2021 
 
 
Principal Investigator’s Name 
Principal Investigator’s Signature 
Date 

Protocol #20-06022291 
Version Date: November 1, 2022 
 
 
List of Abbreviations 
 
 
 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
COA 
Center on Aging 
CRF 
Case Report Form 
CTSC 
Clinical Translational Science Center 
FDA 
Food and Drug Administration 
FMS 
FibroMyalgia Syndrome 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
LARKSPUR 
Lessons in Affect Regulation to Keep Stress and Pain UndeR control 
NYP 
NewYork-Presbyterian 
PA 
Positive Affect 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
WCM 
Weill Cornell Medicine 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Protocol # 20-06022291 
Version Date: November 1, 2022 
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1. Protocol Summary 
 
Full Title: 
Positive Affect as a Source of Resilience for Adults in Chronic Pain 
Short Title: 
LARKSPUR Study 
Principal Investigator: 
M. Carrington Reid, MD, PhD (WCM) 
Anthony D. Ong, PhD (Cornell) 
Study Description: 
Our goal for this study is to evaluate the feasibility, acceptability, and 
effect size of a previously developed online positive affect (PA) skills 
intervention—LARKSPUR (Lessons in Affect Regulation to Keep Stress and 
Pain UndeR control)—in a sample of older adult patients with 
fibromyalgia syndrome (FMS). 
Sample Size: 
N= 150 
Enrollment: 
This study will enroll 150 subjects and screen up to 1,200 subjects 
Study Population: 
Older adults 50 years of age or older with a physician confirmed diagnosis 
of FMS, or a self-report physician diagnosis corroborated by a screening 
measure, that will be stratified by Hispanic, non-Hispanic Black, or non- 
Hispanic other (e.g., White, Asian). 
Enrollment Period: 
2 years 
Study Design: 
This is a longitudinal, randomized behavioral intervention feasibility 
study with internet trainings, daily reporting, and surveys using REDCap 
and BrightOutcome for data collection. 
Description of Sites/ 
Facilities Enrolling 
Participants: 
We will be enrolling participants only through WCM/NYP and will be 
recruiting participants through EPIC, physician referral, flyers, letters, 
social media, and direct recruitment. 
Study Duration: 
September 30, 2024 
Participant Duration: 
4 months 
Primary Objective: 
To maximize relevance and acceptability of content and delivery of 
LARKSPUR intervention among patients with FMS, a chronic pain 
population with known deficits in PA. This aim will establish the feasibility 
(recruitment and retention) and acceptability (helpfulness, satisfaction, 
and impact) of the multicomponent LARKSPUR intervention in patients 
with FMS. 
Secondary Objectives: 
To conduct a randomized pilot trial to estimate the effect size of the 
LARKSPUR intervention in FMS pain (primary outcome), as well PA, 
depressive symptoms, physical functioning, and stress appraisals 
(secondary outcomes), and explore racial/ethnic disparities. We 
hypothesize that intervention participants will report more frequent PA, 
decreased depressive symptoms, enhanced physical functioning, 
improved stress appraisals, and reduced FMS pain (intensity and 
interference) immediately following the intervention (approximately 8 
weeks), and at 1-month post-intervention. 
Exploratory Objectives: 
Not Applicable 
Secondary Endpoints: 
Not Applicable 

Protocol # 20-06022291 
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1.1 Study Objectives 
Our goal for this study is to evaluate the feasibility, acceptability, and effect size of a previously 
developed online positive affect (PA) skills intervention—LARKSPUR (Lessons in Affect Regulation to 
Keep Stress and Pain UndeR control)—in a sample of patients with fibromyalgia syndrome (FMS). 
 
1.1.1 Objectives 
1) To maximize relevance and acceptability of content and delivery of LARKSPUR intervention 
among patients with FMS, a chronic pain population with known deficits in PA. This aim will 
establish the feasibility (recruitment and retention) and acceptability (helpfulness, 
satisfaction, and impact) of the multicomponent LARKSPUR intervention in patients with FMS. 
 
2) To conduct a randomized pilot trial to estimate the effect size of the LARKSPUR intervention 
in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and 
stress appraisals (secondary outcomes) and explore racial/ethnic disparities. We hypothesize 
that intervention participants will report more frequent PA, decreased depressive symptoms, 
enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity 
and interference) immediately following the intervention (approximately 8 weeks), and at 1- 
month post-intervention. 
 
1.1.2 Hypotheses / Research Questions 
We hypothesize that the intervention will lead to more frequent daily PA, which, in addition to 
directly affecting depressive symptoms, will also have indirect effects through enhanced physical 
functioning and improved stress appraisals (resilience mechanisms). Decreased depressive 
symptoms, enhanced physical functioning, and improved stress appraisals, in turn, are 
hypothesized to lead to reduced FMS pain (resilience outcomes). 
 
2. Background and Significance 
Chronic non-cancer pain affects as many as 100 million Americans and is associated with significant 
functional limitations and physical disability. Standard behavioral therapies typically focus on minimizing 
negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are 
therefore needed to develop more effective psychological treatments for chronic pain by identifying new 
targets for intervention. We propose to pilot test a resilience-based intervention that targets positive 
affect (PA) in fibromyalgia syndrome (FMS) patients, a chronic pain population with known deficits in PA 
and an inability to regulate PA in the face of pain. Our goal is to conduct a randomized pilot trial of 
LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control), an online-delivered PA 
skills intervention. Our central hypothesis is that our LARKSPUR program will (a) show acceptability and 
feasibility in engaging and retaining FMS patients and (b) demonstrate greater improvements in PA and 
FMS-related pain and functional impairment. 
 
This proposal for pilot data collection will lay the foundation for a high-quality randomized trial for people 
with FMS. The proposed work holds promise as an effective, low cost, scalable, and readily implementable 
novel non-pharmacologic intervention to help people cope with FMS. By demonstrating the feasibility, 
acceptability, and preliminary efficacy of the LARKSPUR intervention, we hope to improve quality of life, 
as well as the options available for care for millions of people who suffer from FMS. 

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with basic skills for recognizing and savoring positive events and progressing to more complex skills such 
as goal-setting and acts of kindness. 
 
A week will consist of 1-2 days of didactic material and 5-6 days of real-life skills practice and reporting. 
Participants cannot skip ahead and can only progress to the next lesson if they have completed the current 
one, but they can return to old lessons or exercises if they choose. As part of the daily home practice, 
intervention participants will be asked to complete the daily emotion check-in that comprises the 
attention control condition (which takes about 5 minutes to complete). Based on past studies, we 
estimate the time to read through a skill to be about 15 minutes per skill. We also encourage daily 
interaction with the website (home practice, reporting emotions) and estimate the time involved to be an 
additional about 10 minutes. Both the LARKSPUR intervention and emotion-reporting attention control 
conditions, including all home practice and assessments, will be done over the internet from the 
participant's home, or any other location of their choice. The intervention content, emotion check-in, and 
are all mobile-enabled so can be completed on desktop, laptop, tablet, or smartphone with web browser 
access. 
 
Attention Control Condition (n = 75). We sought an attention control condition that provided something 
to engage participants, but was not expensive or burdensome. In past research we have established that 
emotion reporting is acceptable as an attention control condition (retention rates of ~80%, similar to or 
higher than for the intervention), and that participants perceive it as being beneficial, providing some of 
the features of a placebo control. In this daily emotion-reporting attention control condition, participants 
will be asked to report how they are feeling daily for 6-8 weeks which will be emailed to control 
participants. 
 
Participants in the attention control condition will be prompted to report on positive and negative 
emotions experienced in the past day and pain level in the past day, going back a maximum of 24 hours. 
Based on past studies, we expect that this reporting will require approximately 5 minutes per day. Note 
that participants in the LARKSPUR intervention condition will also be completing the daily reporting of 
emotions as part of their home practice. The control group will be completing the same number of 
assessments as the intervention condition at the same time points (baseline, post-intervention, 1-month 
follow-up). 
 
Data collection, transfer, security, and management. Data for the study will come from self-report 
through online. Self-report data will be collected via online assessment (REDCap) at baseline, during the 
6-8-week intervention/control (BrightOutcome), immediate post intervention/control, and at 1-month 
follow-up. In addition, one week of daily stress and emotion surveys coinciding with each of the three 
assessments, for a total of 21 days outside the intervention/control period, will be collected via REDCap. 
The baseline, post-intervention/control, and 1-month follow-up surveys will last 60 and no more than 75 
minutes, and may also be done by phone or videoconference in cases of preference, or due to retention 
follow-up. With participant permission, phone and/or videoconference calls may be recorded for the 
purpose of accurate data collection. The recordings will be deleted after the study is completed and 
participation is not contingent on the participant’s agreement to be recorded. Participants will choose 
whether or not to authorize recordings when completing their informed consent process. 
Data from the online intervention platform will be securely stored on Weill Cornell Medicine and 
BrightOutcome servers, accessible only to IRB-approved co-investigators and BrightOutcome staff. These 
data include number of log-ins, completed home exercises, number of skills completed, and data from the 
daily emotion reporting surveys. All data used for analysis will be de-identified, and no identifiable data 
will ever be stored locally on staff computers and no data are stored locally on participants’ devices. 

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Measures. All participants will complete self-report questionnaire measures at baseline, post- 
intervention, and 1-month follow-up on-line via REDCap or by phone. Participants will complete one week 
of daily 5-10-minute surveys upon completion of each the three assessments, for a total of 21 days. They 
will also complete 5-minute daily check-in surveys during the intervention/control period of 6-8 weeks as 
outlined below in schedule of assessments. 
 
Our selection of measures is guided by the theoretical model in Figure 1. 
 
 
 
 
Figure 1. Theoretical Model 
 
 
Specifically, we hypothesize that the intervention will lead to more frequent daily PA, which, in addition 
to directly affecting depressive symptoms, will also have indirect effects through enhanced physical 
functioning and improved stress appraisals (resilience mechanisms). Decreased depressive symptoms, 
enhanced physical functioning, and improved stress appraisals, in turn, are hypothesized to lead to 
reduced FMS pain (resilience outcomes). The proposed pilot will lay the foundation for a future high- 
quality, adequately powered trial that will explore theoretical moderators, thereby identifying individuals 
most likely to benefit from the LARKSPUR intervention (resilience resources). Finally, it is anticipated that 
the proposed project will foster cross-campus collaborations (i.e., Weill Medical College, Cornell 
University) that will advance research on rheumatic and autoimmune diseases (including FMS), and 
culminate in the development of a novel non-pharmacologic therapeutic approach that is effective, low 
cost, and easily disseminated. 

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4. Study Design 
4.1 Study Population 
Participants 50 years of age or older with a fibromyalgia diagnosis that will be stratified by 
race/ethnicity; non-Hispanic Black, Hispanic, or non-Hispanic other (e.g., White, Asian). 
 
4.2 Inclusion Criteria 
1. Access to daily internet 
2. Male or female 50 years of age or older 
3. Fluent in English and able to read and write in English 
4. Physician diagnosis of FMS AND/OR Score ≥13 on the 6-item, self-report fibromyalgia 
screening tool 
5. Report having pain for at least the last three months 
 
4.3 Exclusion Criteria 
1. Cognitive impairment 
2. Current behavioral treatment for pain 
3. Enrolled in another pain study 
 
4.4 Strategies for Recruitment and Retention 
We will recruit fibromyalgia patients from offices at Weill Cornell Medicine/NewYork-Presbyterian 
(e.g., the Center on Aging (COA), the Cornell Internal Medicine Associates (CIMA), and the Iris Cantor 
Health Center). Co-PI Dr. Cary Reid, PI of the Cornell Roybal Center, has established a successful track 
record recruiting chronic pain patients for Roybal-supported research studies at Weill Cornell 
Medicine/NewYork-Presbyterian. 
 
A total of 150 fibromyalgia patients will be recruited across Aims 1-2 once they have been identified 
by research and referring physicians confirmed to meet eligibility criteria. Based on prior recruitment 
at WCM/NYP we anticipate recruiting double the number of females than males, and will target 
enrollment to an equal number of non-Hispanic Black, Hispanic, or non-Hispanic other (e.g., White, 
Asian) equally between males and females. Participants will open-endedly self-report their race and 
ethnicity; the research team will ensure that the randomization process is stratified by Hispanic, non- 
Hispanic Black, and non-Hispanic other (e.g., White, Asian). 
 
Normal patient participants will be recruited via physician-referred agree to contact sheets (paper or 
REDCap survey), flyers, and/or in-person recruitment. Physicians will utilize an Agree to Contact sheet 
that potential participants fill out with their contact information (phone, email, and/or mailing 
address) and sign agreeing to be contacted directly for the study by any of these methods. 
 
Flyers will be distributed throughout WCM/NYP locations (including the Center on Aging), and 
distributed at senior centers, community centers, and community events. Additionally, co- 
investigators may approach potential participants in WCM/NYP offices (e.g. the Center on Aging), and 
ask if they would be interested in the study, when it is safe to do so under COVID-19 considerations. 
Trained co-investigators may either screen the participants at recruitment sites and/or ask for their 
contact information via the Agree to Contact sheet to be followed up at a time convenient for the 
potential participant. 
 
Research staff will ask physicians at WCM/NYP, to review their patient lists and identify potential 
participants based on eligibility criteria both directly (e.g. email) and at department meetings. 
Research staff may also request EPIC provider reports based on eligibility requirements to reach out 

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to WCM/NYP physicians for permission to contact potential patient participants. Research staff will 
set EPIC search criteria to draw names from all networked EPIC databases accessible to Weill Cornell 
Medicine staff. Identified potential participants will be contacted via recruitment letter, email, or 
Weill/EPIC Connect. Recruitment letters may also be sent to potential participants via EPIC pool of 
WCM/NYP Consent to be Contacted for Research (CCR) patients and chart review to determine 
potential eligibility. Potential subjects will be sent a letter informing them of the study and that they 
will be contacted by a co-investigator who will assess interest in participating in the study. The letter 
will also provide a contact phone or email address that these patients can reach out to express their 
interest/disinterest for participation in the study. 
 
Additional efforts will rely on making study information available on online platforms. Online 
platforms may include, but are not limited to: FMS interest pages on Facebook, participant registries, 
online bulletin boards, mobile apps and websites, etc. Methods include, but are not limited to: posting 
flyers, posting messages describing the project and inviting interested participants to contact study 
members (see “Social Media Posting” document), including study information in e-newsletters, etc. 
Permission from group administrators will be received prior to posting on any social media group 
platform. In addition, online research match databases including but not limited to 
ResearchMatch.org and the Institute for Translational Health Sciences will be added as a recruitment 
method. 
 
Eligible participants will be compensated up to $142 for completing the study. Participants will receive 
$25 for each of the three study assessments (baseline, post-intervention, and 1-month follow up), up 
to $42 ($2 per survey) for the daily 5-10-minute surveys following the study assessments, and $25 for 
the feedback survey. Activities completed during the 6-8 weeks of interaction on BrightOutcome will 
not be compensated. 
 
Additionally, the following measures will be taken to improve retention. First, follow up emails, calls, 
or texts (depending on participant preference) to participants will be utilized to remind patients of 
upcoming study activity (online assessments, etc.). Text message reminders will be administered using 
the Twilio service, embedded via the CTSC in REDCap. Second, throughout the study period, accrual 
and retention rates will be monitored at weekly study meetings through reporting reasons for missed 
approaches, study refusal, and loss to follow up. This will allow the PI and study team members to 
notice quickly issues in accrual and/or retention and the potential reasons for it so that proper action 
can be taken to resolve the issue. Finally, all attempts have been made to keep assessments brief and 
flexible in order to reduce burden on the patients. 
 
5. Registration Procedures 
 
5.1 Subject Registration (WCM only) 
Subjects will be registered within the WRG-CT as per the standard operating procedure for 
Subject Registration. 
 
5.2 Subject Registration (Sub-sites) 
Not applicable. 

Protocol #20-06022291 
Version Date: November 1, 2022 
 
 
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the patients, and any other relevant study documentation will be submitted to the 
appropriate Ethics Committee. Written approval of the study and all relevant study information 
must be obtained before the study center can be initiated or the IP is released to the Investigator. 
Any necessary extensions or renewals of IEC/IRB approval must be obtained for changes to the 
study, such as amendments to the protocol, the ICF, or other study documentation. The written 
approval of the IEC/IRB together with the approved ICF must be filed in the study files. 
 
The Investigator will report promptly to the IEC/IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IEC/IRB as required. On completion of the study, the 
IEC/IRB will be notified that the study has ended. 
 
All agreed protocol amendments will be clearly recorded on a protocol amendment form and will 
be signed and dated by the original protocol approving signatories. All protocol amendments will 
be submitted to the relevant institutional IEC/IRB for approval before implementation, as 
required by local regulations. The only exception will be when the amendment is necessary to 
eliminate an immediate hazard to the trial participants. In this case, the necessary action will be 
taken first, with the relevant protocol amendment following shortly thereafter. 
 
Once protocol amendments or consent form modifications are implemented at the lead site, 
Weill Cornell Medicine, updated documents will be provided to participating sites. Weill Cornell 
Medicine must approve all consent form changes prior to local IRB submission. 
 
Relevant study documentation will be submitted to the regulatory authorities of the 
participating countries, according to local/national requirements, for review and approval 
before the beginning of the study. On completion of the study, the regulatory authorities will be 
notified that the study has ended. 
 
7.2.2 Ethical Conduct of the Study 
The Investigators and all parties involved should conduct this study in adherence to the ethical 
principles based on the Declaration of Helsinki, GCP, ICH guidelines and the applicable national 
and local laws and regulatory requirements. 
 
This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified 
persons, where the benefits of the study are in proportion to the risks. 
 
7.2.3 Informed Consent 
The investigator or qualified designee must obtain documented consent according to ICH-GCP 
and local regulations, as applicable, from each potential subject or each subject’s legally 
authorized representative prior to participating in the research study. Subjects who agree to 
participate will receive an oral consent document prior to speaking to a co-investigator. 
 
 
 
 
 
 
 
 
 
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Informed Consent and HIPAA authorization for participants will occur just prior to their baseline 
interview, by oral consent for participants until virtual consent methods are approved by the 
WCM IRB. For oral consent, a member of the study team will review the ICF and HIPAA 
Authorization document in-full (see Oral Consent Script attachment) by phone or 
videoconference, allowing for questions and reminding the potential subject that participation is 
voluntary. The subject and researcher will each recite their statements. Upon completion, oral 
confirmation of consent to participate will be documented by the study team member. 
 
Once virtual consent processes are established with the JCTO, we will submit an amendment with 
the IRB to conform to these new policies. We feel that with our older adult population, at a higher 
risk to COVID-19, that this is best practices in human subjects for participants not to leave their 
home in order to participate in this study. 
 
The initial ICF, any subsequent revised written ICF and any written information provided to the 
subject must approved by IRB prior to use. The ICF will adhere to IRB/IEC requirements, applicable 
laws and regulations. 
 
7.2.4 Compliance with Trial Registration and Results Posting Requirements 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food 
and Drug Administration Amendments Act (FDAAA), the Sponsor-Investigator of the trial is solely 
responsible for determining whether the trial and its results are subject to the requirements for 
submission to http://www.clinicaltrials.gov. Information posted will allow subjects to identify 
potentially appropriate trials for their disease conditions and pursue participation by calling a 
central contact number for further information on appropriate trial locations and trial site contact 
information. 
 
7.2.5 Record Retention 
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced. After completion of the study, all documents and data 
relating to the study will be kept in an orderly manner by the Investigator in a secure study file. 
Essential documents should be retained for 2 years after the final marketing approval in an ICH 
region or for at least 2 years since the discontinuation of clinical development of the IP. In 
addition, all subject medical records and other source documentation will be kept for the 
maximum time permitted by the hospital, institution, or medical practice. 
 
8. Statistical Considerations 
 
Aim 1. Feasibility and acceptability will be examined by conducting frequency and descriptive statistics 
(i.e., mean, median, standard deviation, range) for enrollment rates, number of sessions completed, 
number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with 
the intervention and perceived helpfulness. Aim 2. Aim 2 will be addressed using a pre-post design. To 
determine the degree to which the LARKSPUR intervention is likely to improve patient outcomes, a post- 
versus-pre- difference will be sought to estimate the change in patients’ outcomes (e.g., pain self- 
management). This is a small feasibility trial to explore the acceptability and feasibility of the intervention 
among racially and ethnically diverse older adults with fibromyalgia. The trial is not powered to estimate 
statistically reliable differences in outcomes. Missing data. All missing data will be assessed for 
missingness (e.g., random or non-random) and appropriate imputation methods will be used. 
 
 
 
 
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