Protocol summary
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Study aim
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to compare the effects of aquatic handpolo exercise and simple aquatic therapy on occupational stress, motor fitness, and perceived self-efficacy in middle-aged women with metabolic syndrome, relative to a control group.
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Design
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Randomized controlled trial with a control group, three parallel groups, single-blind, conducted on 60 participants. Randomization was performed using the Random Allocation Software.
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Settings and conduct
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The study will be conducted in city pools offering aquatic handpolo programs. Employed women aged 30–40 years with clinical signs of metabolic syndrome will be recruited through health centers, sports facilities, and workplace wellness programs. All participants will undergo clinical and laboratory screening, including physical examination and blood tests, to confirm eligibility and readiness for aquatic exercise. Physical fitness will be assessed using functional tests and the PAR-Q+ questionnaire. After informed consent,
Participants will be randomly assigned to one of three groups (aquatic handpolo, Aqua aerobic , or control). Outcome assessors will be blinded to group allocation.
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Participants/Inclusion and exclusion criteria
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Participants of this study will include employed women aged 30 to 40 years who will have clinical symptoms of metabolic syndrome and will be able to participate in the aquatic handpolo exercise program. The main inclusion criteria will be active employment, being within the specified age range, and confirmation of metabolic syndrome criteria through clinical and laboratory assessments.
Exclusion criteria will include the presence of serious cardiovascular or respiratory diseases, medical limitations preventing participation in aquatic exercise, pregnancy,
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Intervention groups
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Aquatic handpolo exercise group, Aqua aerobic exercise
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Main outcome variables
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1. Dynamic Balance, Perceived Self-Efficacy, Motor Performance ,Occupational Stress
General information
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Reason for update
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The date of admission was before the clinical code was recorded, so it was corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190908044722N11
Registration date:
2025-09-29, 1404/07/07
Registration timing:
prospective
Last update:
2026-06-08, 1405/03/18
Update count:
2
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Registration date
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2025-09-29, 1404/07/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-10-02, 1404/07/10
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Expected recruitment end date
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2025-10-26, 1404/08/04
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of Handpolo Exercise on Occupational Stress, Motor Fitness, and Perceived Self-Efficacy in Employed Middle-Aged Women with Metabolic Syndrome: A Three-Arm Randomized Controlled Trial
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Public title
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The Effect of Handpolo Exercise on Occupational Stress, Motor Fitness, and Perceived Self-Efficacy in Employed Middle-Aged Women with Metabolic Syndrome
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Full-time or part-time employment for at least the past six months.
Presence of at least three out of five diagnostic criteria for metabolic syndrome according to the NCEP ATP III guidelines
Waist circumference ≥ 88 cm.
Fasting blood glucose ≥ 100 mg/dL or receiving treatment for elevated blood glucose.
Serum triglycerides ≥ 150 mg/dL or under treatment.
HDL cholesterol < 50 mg/dL or under treatment.
Blood pressure ≥ 130/85 mmHg or taking antihypertensive medication.
Enrollment in a center that offers aquatic Handpolo activities.
Ability and willingness to participate in moderate-intensity aquatic physical activity.
Exclusion criteria:
Pregnancy or intention to become pregnant during the study period.
History of cardiovascular, renal, or severe musculoskeletal disorders that contraindicated exercise.
Engagement in a structured exercise program more than twice per week within the past three months
Use of medications significantly affecting lipid metabolism or cortisol levels, beyond standard treatment for metabolic syndrome
Presence of psychiatric or neurological disorders interfering with adherence to the intervention protocol
Inability to attend at least 80% of the scheduled intervention sessions.
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Age
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From 30 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After completion of the screening process and provision of written informed consent, eligible participants will be randomly assigned in a 1:1:1 ratio to one of three groups: aquatic handpolo exercise, aquatic therapy, or control. To ensure balanced group sizes and minimize allocation bias, randomization will be performed using a block randomization method with variable block sizes (6 and 9). The allocation sequence within each block will be generated in a fully random manner using the Random Allocation Software.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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To reduce the risk of assessment bias, outcome assessors were blinded to group allocation. All measurements related to balance, motor fitness, and occupational stress were conducted by a trained evaluator who was unaware of participants’ group assignments.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-08-20, 1404/05/29
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Ethics committee reference number
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IR.SSRC.REC.1404.069
Health conditions studied
1
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Description of health condition studied
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Metabolic Syndrome
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ICD-10 code
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E88.81
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ICD-10 code description
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Metabolic syndrome
Primary outcomes
1
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Description
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Dynamic Balance
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Timepoint
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Before and after intervention
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Method of measurement
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Dynamic balance will be assessed using the Y-Balance Test, a simplified version of the Star Excursion Balance Test (SEBT). This test evaluates participants’ ability to maintain postural control during functional lower-limb movements. The Y-Balance Test has demonstrated high validity and sensitivity for detecting functional asymmetries and predicting lower-limb injury risk. Intra- and inter-rater reliability has been reported with ICC values between 0.85 and 0.91
2
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Description
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Perceived Self-Efficacy
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Timepoint
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Before and after intervention
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Method of measurement
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Participants’ perceived self-efficacy will be measured using the General Self-Efficacy Scale (GSES), a 10-item questionnaire rated on a 4-point Likert scale. Higher scores indicate greater self-efficacy. The validated Persian version (Nejati et al., 2005) has acceptable reliability (α = 0.81). The scale will be administered pre- and post-intervention in both groups.
3
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Description
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Motor Performance
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Timepoint
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Before and after intervention
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Method of measurement
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Core muscle endurance will be assessed using the McGill protocol, including tests for trunk flexors, extensors, and right and left lateral flexors. Each test will be performed once with a 3-minute rest interval. The maximum time participants can maintain each position will be recorded in seconds. Equipment will include a bench, 60° inclined surface, stopwatch, and straps.
4
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Description
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Occupational Stress
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Timepoint
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Before and after intervention
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Method of measurement
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Occupational stress will be measured using the HSE Stress Questionnaire, which includes 35 items across 7 domains. The tool has demonstrated acceptable reliability (Cronbach’s α = 0.78)
Intervention groups
1
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Description
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Intervention Group 1: Aquatic Handpolo was implemented over 8 weeks in a total of 16 sessions (2 sessions per week) in an indoor pool with a constant depth of 1.2–1.5 m, water temperature maintained at 34–36°C, and air temperature at approximately 24°C. Each session consisted of a 10-minute warm-up, 45 minutes of Handpolo practice, and a 5-minute cool-down. Exercise intensity was progressively adjusted according to participants’ fitness levels using the Borg Rating of Perceived Exertion scale (RPE = 12–14). Activities were carried out in teams (4 players from each team in the water simultaneously) and included passing, dribbling, moving toward the goal, and scoring. All sessions were supervised by a trained Handpolo coach and a certified lifeguard, with blood pressure and physical condition monitored prior to each session to ensure participants’ safety.
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Category
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Rehabilitation
2
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Description
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Intervention group 2: Participants in the aquatic exercise group completed an 8-week water-based aerobic training program conducted twice per week, with each 60-minute session consisting of a 10-minute warm-up, 40-minute main exercise, and 10-minute cool-down. The protocol was adapted from the aquatic aerobic program of Yoo et al. (2021) (12) and modified to match the duration and frequency of the present study. The warm-up involved light whole-body movements in water, followed by the main exercise, which included multi-directional dynamic activities such as water jogging, bouncing, jumping jacks, scissors, kicks, rocking horse, leaping, frog jumps, leg curls, twisting heel-toe motions, and ankle mobility drills.
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Category
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Rehabilitation
3
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Description
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Control Group (Usual Care with Standard Medications):Participants in the control group will continue their usual daily activities without receiving any structured intervention. They may continue their regular medications for metabolic syndrome as prescribed by their physician, but will not receive any new exercise or aquatic program. All assessments and monitoring (occupational stress, motor fitness, and perceived self-efficacy) will be conducted similarly to the intervention groups to ensure comparable conditions and participant safety.
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Category
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Diagnosis
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Urmia University
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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The ethical review board overseeing this study recommended against the release of IPD due to concerns about potential misuse or misinterpretation of the data outside of its intended context.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The analysis of information obtained from the results of the interventions on Knee Proprioception and Gait Speed can be published
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When the data will become available and for how long
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From the time the article was published until a year later
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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Provided Someone wants to do a similar research project
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From where data/document is obtainable
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r.khanmohamadi65@yahoo.com
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What processes are involved for a request to access data/document
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Send request by email
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Comments
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