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DREAMS

cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – Clinical Management

South Africa, 2024 - 2026
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Reference ID
AHRI.LAPIS.ESource.Clinical.Management.2025.v1
Producer(s)
Prof. Maryam Shahmanesh, Dr. Limakatso Lebina
Collections
Multilevel HIV Prevention
Metadata
Documentation in PDF DDI/XML JSON
Created on
Feb 06, 2025
Last modified
Feb 06, 2025
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9847
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Data file: AHRI.LAPIS.ESource.Clinical.Management.2025.v1

Cases: 3457
Variables: 690

Variables

cs_quest_stoptime
Questionnaire - Stop time
partic_capapble_self_int
For Interviewer: Is the participant comfortable to complete the self-interview b
cs_sex_hist_done
Was the participant asked about Sexual History?
cs_everhadsex
Have you ever had sex?
cs_share12mth_numsexpartn
Are you willing to share the number of different people have you had sex with in
cs_12mth_numsexpartn
How many people have you had sex with in the past 12 months (including your husb
cs_condomless_3months
Have you had any sex without a condom in the last 3 months? (condom less sex)?
cs_condomless_72hours
Have you had any sex without a condom in the last 72 hours / last 3 days (condom
cs_knwpartnstatus_curr
Do you know the HIV status of your current sexual partner?
cs_partnstatus_curr
What is the HIV status of your current sexual partner?
cs_gift_forsex
Did you ever give or were you ever given a gift in order to have sex? It could b
cs_sasa_expr
Has your partner/most recent partner done at least one of the following things t
srs_useviol_12mths
Have you used physical or sexual violence on your partner in the last 12 months?
cs_drug_alc_smok_done
Was the Participant asked about Tobacco, Alcohol and Drug Use?
cs_smoke_hist
In your whole life up to now, have you ever smoked a cigarette?
cs_smoked_perday
How many cigarettes do you smoke in a day?
cs_everdrink
In your whole life up to now, have you ever drunk one drink of alcohol (e.g. a b
cs_daysdrunk_mths
How many days have you drunk at least one drink in the past month? [number of da
cs_more5drinks_day
How many days have you drunk 5 or more drinks (in succession) on one or more day
cs_usedoth_drugs_0
Have you used any of these drugs in the past 3 months (Tick all that apply) - No
cs_usedoth_drugs_1
Have you used any of these drugs in the past 3 months (Tick all that apply) - Ca
cs_usedoth_drugs_2
Have you used any of these drugs in the past 3 months (Tick all that apply) - Sn
cs_usedoth_drugs_3
Have you used any of these drugs in the past 3 months (Tick all that apply) - In
cs_usedoth_drugs_4
Have you used any of these drugs in the past 3 months (Tick all that apply) - Me
cs_usedoth_drugs_5
Have you used any of these drugs in the past 3 months (Tick all that apply) - Co
cs_usedoth_drugs_6
Have you used any of these drugs in the past 3 months (Tick all that apply) - He
cs_usedoth_drugs_7
Have you used any of these drugs in the past 3 months (Tick all that apply) - Cl
cs_usedoth_drugs_96
Have you used any of these drugs in the past 3 months (Tick all that apply) - Ot
cs_usedoth_drugs_93
Have you used any of these drugs in the past 3 months (Tick all that apply) - Pr
cs_othdrug_oth
Please specify more details on the kind of other drugs you have used?
cs_population_done
Was the Participant asked with which population group they associated with?
cs_populations_1
With which of the following population does the participant identify? (Tick all
cs_populations_2
With which of the following population does the participant identify? (Tick all
cs_populations_3
With which of the following population does the participant identify? (Tick all
cs_populations_4
With which of the following population does the participant identify? (Tick all
cs_populations_5
With which of the following population does the participant identify? (Tick all
cs_populations_6
With which of the following population does the participant identify? (Tick all
cs_populations_93
With which of the following population does the participant identify? (Tick all
cs_admin_date
Date form was administered
fd_screen_date
Follow Up Screening date
fd_staff_code
Staff Code
fd_condom_first_24h
Did the participant use condoms/abstain for the first 24 hours after insertion?
fd_kept_ring_28days
Did the participant kept the ring insitu for the last 28 days since insertion?
fd_any_negative_experience
Does the participant has any negative experience to report?
fd_list_neg_experience_1
Please list the the negative experience/s - Felt Discomfort
fd_list_neg_experience_2
Please list the the negative experience/s - Came out during sex
fd_list_neg_experience_3
Please list the the negative experience/s - Came out on its own
fd_list_neg_experience_4
Please list the the negative experience/s - Doesn't want the ring anymore
fd_list_neg_experience_5
Please list the the negative experience/s - Having an STI
fd_list_neg_experience_6
Please list the the negative experience/s - Abnormal pain
fd_list_neg_experience_7
Please list the the negative experience/s - Don't feel protected by the Ring
fd_list_side_effects_0
Does the participant has any of the following side effects? - No side effects
fd_list_side_effects_1
Does the participant has any of the following side effects? - Urinary tract infe
fd_list_side_effects_2
Does the participant has any of the following side effects? - Vaginal discharge
fd_list_side_effects_3
Does the participant has any of the following side effects? - Pelvic or lower ab
po_assess_date
Assessment date
po_given_birth
Since the last visit, has the participant given birth?
po_num_infants
Number of infants
po_preg_outcome
Pregnancy outcome
po_preg_outcome_date
Date of pregnancy outcome
po_oth_ae_outcome
Any other adverse outcomes (incl encephaly, hernia, HIV)?
po_oth_ae_outcome_desc
Please describe other adverse outcomes
po_delivery_mode
Mode of delivery
po_weeks_to_misc_term
How many weeks pregnant were you when you had the miscarriage/termination or chi
po_any_problem_anom
Any other problems or anomalies with birth?
po_specify_problem_anom
Please specify details on other problems or anomalies with birth
po_data_source
How were the data reported and captured?
ih_infant_sex
Infant Gender
ih_birth_weight
Birthweight
ih_infant_alive
Is the infant still alive?
ih_time_to_death
When did your baby die?
ih_how_is_baby_fed_current
How is your baby currently being fed?
ih_descr_baby_health
How would you describe your baby's health from birth until now?
ih_calc_low_birth_weight
Calculate - Low birth weight
ec_discuss_emcontrac
Was emergency contraceptives discussed with the participant?
ec_form_date
Date form completed
ec_used_emcontrac_3mths
Did the participant take emergency contraceptives within the last 3 months?
ec_uptake_emcontrac
Did the participant uptake Emergency Contraception?
vs_exam_done
Was the participant's Vital Signs measured and Physical examination done?
vs_starttime
Vitals - Start time
vs_meas_temp
Was Temperature measured?
vs_heart_temp
Temperature (Degrees Celsius)
vs_meas_heart_rate
Was Heart Rate measured?
vs_heart_rate
Record Heart Rate (bpm)
vs_meas_bp
Was Blood Pressure measured?
vs_r1_bp_sys
First BP Reading - Systolic
vs_r1_bp_dia
First BP Reading - Diastolic
vs_r2_bp_sys
Second BP Reading - Systolic
vs_r2_bp_dia
Second BP Reading - Diastolic
vs_r3_bp_sys
Third BP Reading - Systolic
vs_r3_bp_dia
Third BP Reading - Diastolic
vs_pe_nerve
Central Nervous System
vs_pe_nerve_abn
Specify abnormality for: Central Nervous System
vs_pe_cardio
Cardiovascular System
vs_pe_cardio_abn
Specify abnormality for: Cardiovascular System
vs_pe_resp
Respiratory System
vs_pe_resp_abn
Specify abnormality for: Respiratory System
vs_pe_gastro
Gastrointestinal System
vs_pe_gastro_abn
Specify abnormality for: Gastrointestinal System
vs_pe_skin
Skin
vs_pe_skin_abn
Specify abnormality for: Skin
vs_pe_joints
Joints
vs_pe_joints_abn
Specify abnormality for: Joints
vs_stoptime
Vitals - Stop time
rl_reviewed_date
Review date
rl_reviewed_elisa_hiv
Was the Elisa HIV Result reviewed?
rl_recall_for_elisa_hiv
Should the participant be recalled to the clinic for a visit with the Study Doct
rl_reviewed_dbs_hiv
Was the DBS HIV Result reviewed?
rl_recall_for_dbs_hiv
Should the participant be recalled to the clinic for a visit with the Study Doct
rl_reviewed_elisa_vl
Was the Elisa Viral Load Result reviewed?
rl_recall_for_elisa_vl
Should the participant be recalled to the clinic for a visit with the Study Doct
rl_reviewed_dbs_vl
Was the DBS Viral Load Result reviewed?
rl_recall_for_dbs_vl
Should the participant be recalled to the clinic for a visit with the Study Doct
rl_reviewed_cd4
Was the CD4 Result reviewed?
rl_recall_for_cd4
Should the participant be recalled to the clinic for a visit with the Study Doct
rl_reviewed_truv
Was the Truvado drug level Result reviewed?
rl_recall_for_truv
Should the participant be recalled to the clinic for a visit with the Study Doct
rl_reviewed_nhls
Was the NHLS Result reviewed?
rl_recall_for_nhls
Should the participant be recalled to the clinic for a visit with the Study Doct
rl_upload_docs
Please use this field to upload any lab reports and documents. (Optional)
rl_calc_recall
Calculated - Recalling participant for a clinic visit
rp_was_recalled
Was the participant recalled to the clinic?
rp_recalled_date
On which date was the participant Recalled?
fs_health_pro_done
Was the participant counselled about Health Promotion?
fc_starttime
Health Promotion - Start time
fc_diet
Discussing Diet:
fc_exercise
Discussing Exercise:
fc_alcohol
Discussing Alcohol consumption:
fc_mental_health
Discussing Mental Health Issues: Anxious, depresses, sleeplessness, worried
fc_fertility_advice
Overall fertility advice
fc_contraception_1
Types of contraception discussed - Condoms
fc_contraception_2
Types of contraception discussed - Oral contraceptive pills
fc_contraception_3
Types of contraception discussed - Injectable contraceptives
fc_contraception_4
Types of contraception discussed - Implants
fc_contraception_5
Types of contraception discussed - IUD/loop
fc_contraception_6
Types of contraception discussed - Sterilization
fc_safmt_sex_counseling_1
Counseling on Safer Sex Health - Condom
fc_safmt_sex_counseling_2
Counseling on Safer Sex Health - Regular HIV Testing
fc_safmt_sex_counseling_3
Counseling on Safer Sex Health - Partner HIV Testing (know your partner's status
fc_safmt_sex_counseling_4
Counseling on Safer Sex Health - Genital Hygiene
fs_was_condom_disp
Did you dispense condoms to the participant?
fs_num_male_condom
How many male condoms were dispensed? (Number of individual condoms, not package
fc_counsel_vmmc
Counselling around the benefits of voluntary medical male circumcision (VMMC)
fc_stoptime
Health Promotion - Stop time
ce_check_elig_done
Was the participant's Suitability for PrEP checked?
ce_starttime
Checking Eligibility - Start time
ce_elig_known_hiv_pos
Is the participant known to be HIV Positive?
ce_elig_hiv_neg
Does the participant have a HIV Negative confirmatory test result?
ce_elig_sexual_activ
Is the participant sexually active?
ce_pep_unpotect_sex
Have you had unprotected Sex with a stranger or a person of unknown HIV status?
ce_pep_took_prep
Have you been taking your PrEP medication continuously for 7 days before having
ce_pep_busted_condom
Have you had a Busted condom while having sex with a person of unknown status?
ce_pep_sex_assaulted
Have you been sexually assaulted?
ce_pep_shared_needle
Have you shared a Needle or any other sharp equipment to inject drugs?
ce_pep_expos_fluids
Have you been exposed to contagious body fluids/semen/blood?
ce_update_pep
Did the participant uptake PEP?
ce_will_contin_prep
Is the participant happy to continue on PrEP?
ce_contin_same_prep
Is the participant continuing on the same method of PrEP ([end_of_study_arm_1][c
ce_elig_risk_hiv
Is the participant at significant risk of acquiring HIV infection? *Adolescents
ce_elig_num_sex_partner
With how many different persons did the participants had sex with, 12 months?
ce_elig_num_unpotect
Has the participant had unprotected sex with HIV positive partners or partners w
ce_elig_under_influe
Did the participant ever had sex while under the influence of alcohol and/or dru
ce_elig_trans_sex
Over the past year, has the participant ever engaged in the exchange of sex for
ce_elig_will_take_tablet
Is the participant willing and able to take a tablet for HIV prevention?
ce_elig_will_use_condom
Does the participant fully understands that the protection provided by PrEP is n
ce_elig_will_attnd_visits
Is the participant willing and able to attend 3 monthly Clinic Visits?
ce_elig_confirm_cntdetails
Have you checked that you have the correct Contact Details to track the the Part
ce_consid_elig_prep
Is the participant consider Suitable to be initiated on PrEP?
ce_not_consid_prep_reas
Please provide the reason why the participant is not deemed suitable for PrEP
ce_oral_info_discussed
Has the information regarding the Oral PrEP (TDF/FTC) been discussed with the pa
ce_oral_info_questions
Does the participant have any questions about the Injectable Oral PrEP (TDF/FTC)
ce_screen_oral
Continue with screening for Oral PrEP (TDF/FTC)?
ce_oral_in_population
All young men and women aged 15-30 who are residing in the 40 administrative clu
ce_oral_in_hiv_neg
Documented HIV negative test?
ce_oral_in_elig_prep
Eligible for PrEP according to South African guidelines and/or already on oral P
ce_oral_in_schedule
Understand the required dosing schedule and HIV testing?
ce_oral_in_share_peernav
Aware that their details can be shared with a peer navigator to support their fo
ce_oral_ex_allergy_ip
History or presence of allergy to the study drugs or their components?
ce_oral_ex_egrf
Persistent eGFR of < 60 mmol/l at baseline?
ce_cab_info_discussed
Has the information regarding the Injectable PrEP (CABLA) been discussed with th
ce_cab_info_questions
Does the participant have any questions about the Injectable PrEP (CABLA)?
ce_screen_cab
Continue with screening for Injectable PrEP (CABLA)?
ce_cabla_in_population
Is the participant a Young man and woman aged 16-30 who are residing in the 20 a
ce_cabla_und_schedule
Does the participant understand the required dosing schedule and HIV testing?
ce_cabla_und_pregnant
Does the participant sufficiently understand that CABLA can and will be offered
ce_cabla_aware_peernav
Is the participant aware that there details can be shared with a peer navigator
ce_cabla_consented
Did the participant provide informed consent (aged 18 and over) or, informed ass
ce_cabla_ex_allergy
Does the participant has a history or presence of allergy to the study drugs or
ce_cabla_ex_no_understand
Is the following statement true for the participant?: Provide informed consent (
ce_cabla_ex_any_conditions
Does the participant has any of these conditions?: Severe mental health disorder
ce_cabla_ex_liver_test
Does the participant had an Abnormal liver function tests (ALT more than two tim
ce_cabla_ex_prohibit_meds
Is the participant taking medication that is contraindicated: Carbamazepine, Oxc
ce_dap_info_discussed
Has the information regarding the Dapi ring been discussed with the participant?
ce_dap_info_questions
Does the participant have any questions about the Dapi ring?
ce_screen_dapi_ring
Continue with screening for Dapi ring?
ce_born_female
Was the participant born a female?
ce_genital_reassign
Have the participant undergone any genital reassignment?
ce_vaginal_sex_only
Does the participant normally have vaginal sex only?
ce_curr_pregnant
Is the participant currently pregnant or delivered/miscarried in the last 6 week
ce_have_sti_sores
Does the participant have any vaginal discharge or sores around the vagina?
ce_dap_in_population
All women aged 18-30 who are residing in the 40 administrative clusters?
ce_dap_in_hiv_neg
Documented HIV negative test?
ce_dap_in_elig_prep
Eligible for PrEP according to South African guidelines and/or already on oral P
ce_dap_in_schedule
Understand the required dosing schedule and HIV testing?
ce_dap_in_share_peernav
Aware that their details can be shared with a peer navigator to support their fo
ce_dap_ex_allergy_ip
History or presence of allergy to the study drugs or their components?
ce_uptake_prep
Did the participant uptake PrEP?
ce_prep_method
What method of PrEP Treatment will the participant be taking?
ce_not_uptake_prep_reas
Please provide the reason why the participant is not uptake PrEP
ce_uptake_peppack
Would the participant accept a PEP pack?
ce_not_uptake_peppack_reas
Please provide the reason why the participant did not uptake the PEP pack
ce_uptake_peer_supp
Would the participant like to uptake Peer Support for adhering to PrEP?
ce_checked_by_doctor
Was the Eligibility for PrEP checked by the Study Physician?
ce_checked_date
Date checked
ce_checked_approved
Is the participant approved to start PrEP?
ce_stoptime
Checking Eligibility - Stop time
ce_calc_prep_visit
Calculated PrEP Visit 1 = Initial PrEP visit
ce_calc_send_expand
Calculate - to send to EXPAND project Pilot
ce_calc_send_expand_prod
Calculate - to send to EXPAND project Production
ce_calc_elig_cabla
Calculate - Eligible for Injectable PrEP - CABLA
ce_calc_screen_dapi
Calculate - Screening Outcome for Dapi ring
ce_calc_elig_dapi
Calculate - Eligible for Dapi ring
ce_calc_dur_end_elig
Calculate Duration till end of Checking Eligibility
ep_date
Date:
ep_diagnosis
Diagnosis
ep_any_allergies
Any known allergies?
ep_allergies
Known allergies
ep_medication
Medication name
ep_med_unit_oral
Medication unit - Oral PrEP
ep_med_unit_ring
Medication unit - Dapi ring
ep_med_unit_injection
Medication unit - Injectable PrEP CABLA
ep_who_dispense
Who is the dispenser?
ep_disp_date
Date dispensed
ep_disp_com
Additional Comments
st_switching_treatment
Is the participant switching PrEP treatments?
st_swap_treatment_date
Date treatments are swapped
st_prevoius_treatment
On which PrEP treatment was the participant?
st_new_treatment
What is the new PrEP treatment for the participant?
st_reas_switch_method_1
Why is the participant switching their PrEP Treatment? - Experiencing short term
st_reas_switch_method_2
Why is the participant switching their PrEP Treatment? - Worried about experienc
st_reas_switch_method_3
Why is the participant switching their PrEP Treatment? - Don't want to or findin
st_reas_switch_method_4
Why is the participant switching their PrEP Treatment? - Injection site issues e
st_reas_switch_method_5
Why is the participant switching their PrEP Treatment? - Challenges or Discomfor
st_reas_switch_method_6
Why is the participant switching their PrEP Treatment? - Finding it difficult to
st_reas_switch_method_7
Why is the participant switching their PrEP Treatment? - Challenges with the PrE
st_reas_switch_method_8
Why is the participant switching their PrEP Treatment? - Partner/s or family mem
st_reas_switch_method_9
Why is the participant switching their PrEP Treatment? - Stigma (challenges from
st_reas_switch_method_10
Why is the participant switching their PrEP Treatment? - Inconvenience of the ty
st_reas_switch_method_11
Why is the participant switching their PrEP Treatment? - Reduced HIV risk - e.g.
st_reas_switch_method_12
Why is the participant switching their PrEP Treatment? - Increased HIV risk (pe
st_reas_switch_method_13
Why is the participant switching their PrEP Treatment? - Feel more confident wit
st_reas_switch_method_14
Why is the participant switching their PrEP Treatment? - Other prevention strate
st_reas_switch_method_15
Why is the participant switching their PrEP Treatment? - Want to try a different
st_reas_switch_method_16
Why is the participant switching their PrEP Treatment? - Pregnancy
st_reas_switch_method_17
Why is the participant switching their PrEP Treatment? - Prefer not to take PrEP
st_reas_switch_method_96
Why is the participant switching their PrEP Treatment? - Other reason
st_reas_switch_method_oth
Please provide the other reason why the participant switched PrEP Treatment
ps_report_stop_prep
Did the participant reported that they stopped taking PrEP?
rs_prep_stop_date
On which date did the participant stop taking PrEP?
ps_prep_stop_reas_1
What are the reasons for stopping PrEP? - Don't have sex currently.
ps_prep_stop_reas_2
What are the reasons for stopping PrEP? - Have fewer partners.
ps_prep_stop_reas_3
What are the reasons for stopping PrEP? - Partner/s or family member/s objected
ps_prep_stop_reas_4
What are the reasons for stopping PrEP? - Trust partner/s or knows their status.
ps_prep_stop_reas_5
What are the reasons for stopping PrEP? - Other prevention strategies are suffic
ps_prep_stop_reas_6
What are the reasons for stopping PrEP? - Finding it difficult to engage with Pr
ps_prep_stop_reas_7
What are the reasons for stopping PrEP? - Worried about experiencing short term
ps_prep_stop_reas_13
What are the reasons for stopping PrEP? - Experiencing short term side effects.
ps_prep_stop_reas_8
What are the reasons for stopping PrEP? - Worried about experiencing long term s
ps_prep_stop_reas_9
What are the reasons for stopping PrEP? - Don't feel adequately protected with P
ps_prep_stop_reas_10
What are the reasons for stopping PrEP? - Don't want to or finding it difficult
ps_prep_stop_reas_11
What are the reasons for stopping PrEP? - Prefer not to take PrEP as pregnant or
ps_prep_stop_reas_14
What are the reasons for stopping PrEP? - Challenges with the PrEP schedule for
ps_prep_stop_reas_15
What are the reasons for stopping PrEP? - Stigma (challenges from hiding the PrE
ps_prep_stop_reas_16
What are the reasons for stopping PrEP? - Reduced HIV risk - e.g. don't have sex
ps_prep_stop_reas_17
What are the reasons for stopping PrEP? - Pregnancy
ps_prep_stop_reas_18
What are the reasons for stopping PrEP? - Prefer not to take PrEP as pregnant or
ps_prep_stop_reas_12
What are the reasons for stopping PrEP? - Seroconverted
ps_prep_stop_reas_96
What are the reasons for stopping PrEP? - Other
ps_prep_stop_reas_lapis_1
What are the reasons for stopping PrEP? - Experiencing short term side effects.
ps_prep_stop_reas_lapis_2
What are the reasons for stopping PrEP? - Worried about experiencing long term s
ps_prep_stop_reas_lapis_3
What are the reasons for stopping PrEP? - Don't want to or finding it difficult
ps_prep_stop_reas_lapis_4
What are the reasons for stopping PrEP? - Injection site issues e.g. pain
ps_prep_stop_reas_lapis_5
What are the reasons for stopping PrEP? - Challenges or Discomfort in inserting
ps_prep_stop_reas_lapis_6
What are the reasons for stopping PrEP? - Finding it difficult to engage with Pr
ps_prep_stop_reas_lapis_7
What are the reasons for stopping PrEP? - Challenges with the PrEP schedule for
ps_prep_stop_reas_lapis_8
What are the reasons for stopping PrEP? - Partner/s or family member/s objected
ps_prep_stop_reas_lapis_9
What are the reasons for stopping PrEP? - Stigma (challenges from hiding the PrE
ps_prep_stop_reas_lapis_10
What are the reasons for stopping PrEP? - Inconvenience of the type of PrEP
ps_prep_stop_reas_lapis_11
What are the reasons for stopping PrEP? - Reduced HIV risk - e.g. don't have sex
ps_prep_stop_reas_lapis_12
What are the reasons for stopping PrEP? - Increased HIV risk (perceived or actu
ps_prep_stop_reas_lapis_13
What are the reasons for stopping PrEP? - Feel more confident with a different P
ps_prep_stop_reas_lapis_14
What are the reasons for stopping PrEP? - Other prevention strategies are suffic
ps_prep_stop_reas_lapis_15
What are the reasons for stopping PrEP? - Want to try a different PrEP
ps_prep_stop_reas_lapis_16
What are the reasons for stopping PrEP? - Pregnancy
ps_prep_stop_reas_lapis_17
What are the reasons for stopping PrEP? - Prefer not to take PrEP as pregnant or
ps_prep_stop_reas_lapis_18
What are the reasons for stopping PrEP? - Seroconverted
ps_prep_stop_reas_lapis_96
What are the reasons for stopping PrEP? - Other
ps_prep_stop_reas_oth
Describe other reason/s for stopping PrEP
rs_prep_fut_uptake
Would you be willing to take PrEP again in the future?
mc_counsel_date
Medication Counselling Date
Total: 690
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