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Trial registered on ANZCTR


Registration number
ACTRN12618001365257
Ethics application status
Approved
Date submitted
13/07/2018
Date registered
14/08/2018
Date last updated
17/05/2022
Date data sharing statement initially provided
17/05/2022
Date results provided
17/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Indigenous Birthing in an Urban Setting (IBUS) Study: Improving maternal infant health
care for Aboriginal and Torres Strait Islander women and infants
Scientific title
The Indigenous Birthing in an Urban Setting (IBUS) Study: Improving maternal infant health
care for Aboriginal and Torres Strait Islander women and infants through a multi-agency partnership
Secondary ID [1] 295328 0
Nil
Universal Trial Number (UTN)
Trial acronym
IBUS
Linked study record
ACTRN12615001278527 is a sub-study of the Indigenous Birthing in an Urban Setting (IBUS) study:
“Stop Smoking in its Tracks”: a single arm intervention study of a smoking cessation program for women receiving maternity care through the Birthing in Our Community program. A sub-study of the Indigenous Birthing in an Urban Setting (IBUS) study

Health condition
Health condition(s) or problem(s) studied:
infant health 308534 0
preterm birth 308535 0
Condition category
Condition code
Public Health 307503 307503 0 0
Health service research
Reproductive Health and Childbirth 307767 307767 0 0
Antenatal care
Reproductive Health and Childbirth 307768 307768 0 0
Breast feeding
Reproductive Health and Childbirth 307769 307769 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 307770 307770 0 0
Complications of newborn
Reproductive Health and Childbirth 307771 307771 0 0
Contraception
Reproductive Health and Childbirth 307772 307772 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Birthing in Our Community is a complex intervention designed to improve maternal and infant health outcomes for Indigenous families in an urban setting. Launched in 2013, Birthing in Our Community was developed in partnership between the Mater Mothers Hospital, and two local Aboriginal community-controlled health organisations: the Institute for Urban Indigenous Health and the Aboriginal and Torres Strait Islander Community Health Service Brisbane Ltd.

Key components of the intervention include:
• Indigenous governance (operating through a Steering Committee) functioning in accordance with Terms of Reference and underpinned by a MOU
• A community-based Midwifery Group Practice (MGP), which provides continuity of carer to enrolled women throughout pregnancy, birth and up to six weeks postnatally. Care is provided according to hospital guidelines and protocols in the home, at community venues where regular cultural and education days are held, or in the hospital
• 24/7 access to caseload midwife who works in MGP on annualised salary with each woman allocated a primary midwife. Midwife support during birthing is likely to be by a known midwife
• Location for birth is the Birth Suite (no homebirth or Birth Centre services provided)
• Indigenous Maternal Infant Health/ Family Support Workers and Indigenous student midwives work with the caseload midwives to provide culturally tailored care
• Referral to Indigenous community support agencies as required; All women are offered a formal handover to child health services with other referrals as required (e.g. paediatric, allied health)
• Clinical / cultural supervision for staff
• Indigenous Liaison Officers are based in the hospital to strengthen culturally responsive care and support
• Access to medical staff, allied health professionals, social workers, child safety officers and other professionals as required (e.g. Diabetic educator)
• Discharge letter to referral doctor and referrals to community support agencies as required
Referred to as Group 1, data collected Jul 2013 to Dec 2019
Intervention code [1] 301658 0
Treatment: Other
Comparator / control treatment
Ngarrama Indigenous Maternity Service (Active Concurrent Control Group 4 - Jul 2013 to Dec 2019) at RBWH
• A hospital-based Midwifery Group Practice (MGP), which provides continuity of carer to enrolled women throughout pregnancy, birth and up to six weeks postnatally. Care is provided according to hospital guidelines and protocols, regardless of setting (women’s homes, community venues or hospital)
• 24/7 access to MGP midwives who work in a small team and are on annualised salary with each woman allocated a primary midwife. Midwife support during birthing is likely to be by a known midwife.
• Location for birth may be in the Birth Suite or the co-located Birth Centre (eligibility criteria apply);
• Access to Cultural Capability Officers of the Metro North Aboriginal and Torres Strait Islander Health Unit who provide additional cultural guidance and support.

Standard Care (Historical Control Group 2 - Jan 2009 to Jun 2013 & Active Concurrent Control Group 5 - Jul 2013 to Dec 2019, at both hospitals )
• Antenatal care may be received from community based general practitioner, hospital based midwives or doctors who rotate throughout the service on rosters. Midwife support during birthing is likely to be by a person the woman has never met. Postnatal care or phone call from a rostered community midwife might take place if the woman meets the criteria for early discharge—before 48 h for vaginal birth and 72 h for caesarean section usually for up to less than 2 weeks
• Women can call the hospital birthing suite in an emergency
• Location for birth same as other groups for the hospitals
• Some aspects of the Intervention may be present but not all and there is no overarching Indigenous governance or clinical / cultural supervision for staff


Standard Care non-Indigenous babies and their mothers (Historical Control Group 3 - Jan 2009 to Jun 2013 & Active Concurrent Control Group 6 - Jul 2013 to Dec 2019, at both hospitals
• Antenatal care may be received from community based general practitioner, hospital based midwives or doctors who rotate throughout the service on rosters. Midwife support during birthing is likely to be by a person the woman has never met. Postnatal care or phone call from a rostered community midwife might take place if the woman meets the criteria for early discharge—before 48 h for vaginal birth and 72 h for caesarean section usually for up to less than 2 weeks
• Women can call the hospital birthing suite in an emergency
• Location for birth same as other groups for the hospitals
• Some aspects of the Intervention may be present for some women (e.g. MGP care)
Control group
Active

Outcomes
Primary outcome [1] 306475 0
Proportion of women giving birth preterm (< 37 weeks gestation) - data derived from hospital records
Timepoint [1] 306475 0
Birth
Primary outcome [2] 306476 0
Proportion of women who attend five or more antenatal visits during pregnancy - data derived from hospital records
Timepoint [2] 306476 0
Birth
Primary outcome [3] 307246 0
The proportion of women smoking after 20 weeks gestation - data derived from hospital records
Timepoint [3] 307246 0
Birth
Secondary outcome [1] 349638 0
Gestation at first antenatal visit to a health provider, at booking into hospital (weeks, Mean, Median, Range, First trimester (Yes/No))- data derived from hospital records
Timepoint [1] 349638 0
At booking
Secondary outcome [2] 349731 0
Number of total antenatal visits (Mean, SD, Median, Range, <5 visits, 5 and more visits)- data derived from hospital records
Timepoint [2] 349731 0
Birth
Secondary outcome [3] 349734 0
Women having attended antenatal education sessions (Yes/No)-data derived from survey designed for this study
Timepoint [3] 349734 0
8 weeks postnatal
Secondary outcome [4] 349735 0
Smoking status at booking (Yes/No), during the first 20 weeks (Yes/No), and after the first 20 weeks (Yes/No), at discharge (Yes/No) and six months postnatal (Yes/No), and number of cigarettes intake each day if smokers (Mean, SD)- data derived from hospital records and survey designed for this study
Timepoint [4] 349735 0
Birth, 8 weeks postnatal and 6 months postnatal
Secondary outcome [5] 349736 0
Pregnancy complications: Gestational diabetes (Yes/No), Pregnancy induced hypertension (Yes/No), Antenatal haemorrhage (Yes/No) - data derived from hospital records
Timepoint [5] 349736 0
Birth
Secondary outcome [6] 349739 0
Non-pharmacological analgesia (Yes/No)- data derived from hospital records
Timepoint [6] 349739 0
Birth
Secondary outcome [7] 349740 0
Pharmacological analgesia in labour (Epidural/spinal analgesia, Narcotic analgesia, Nitrous oxide gas) -data derived from hospital records
Timepoint [7] 349740 0
Birth
Secondary outcome [8] 349741 0
Onset of labour (Induced, No labour, Spontaneous) - data derived from hospital records
Timepoint [8] 349741 0
Birth
Secondary outcome [9] 349742 0
Mode of birth (Non-instrumental vaginal birth, Instrumental vaginal birth, Elective Caesarean section, Emergency Caesarean section)- data derived from hospital records
Timepoint [9] 349742 0
Birth
Secondary outcome [10] 349744 0
Management of third stage of labour (Active, Physiological)- data derived from hospital records
Timepoint [10] 349744 0
On completion of third stage of labour
Secondary outcome [11] 349745 0
Postpartum haemorrhage (<500ml, 500-999ml, 1000-1499ml, 1500ml and more or with blood transfusion) -data derived from hospital records
Timepoint [11] 349745 0
During labour or prior to hospital discharge
Secondary outcome [12] 349746 0
Perineal trauma status (Intact/1st degree tear, 2nd degree tear, 3rd/4th degree tear) - data derived from hospital records
Timepoint [12] 349746 0
Birth
Secondary outcome [13] 349747 0
Episiotomy (Yes/No)- data derived from hospital records
Timepoint [13] 349747 0
Birth
Secondary outcome [14] 349748 0
Women having a known caregiver for labour and birth (Yes/No)- data derived from hospital records and survey designed for this study
Timepoint [14] 349748 0
Birth and 8 weeks postnatal
Secondary outcome [15] 349749 0
Birth weight (grams, Mean, SD, <2500g, 2500g or more)-data derived from hospital records
Timepoint [15] 349749 0
Birth
Secondary outcome [16] 349750 0
Apgar score at 5 minutes (<7, 7 or above) -data derived from hospital records
Timepoint [16] 349750 0
Five minutes after birth
Secondary outcome [17] 349751 0
Admission to a separate neonatal nursery (Yes/No)- data derived from hospital records
Timepoint [17] 349751 0
At discharge from hospital following birth
Secondary outcome [18] 349753 0
Perinatal outcomes (Liveborn survived, Liveborn neonatal death prior discharge from hospital, stillbirth) -data derived from hospital records
Timepoint [18] 349753 0
At discharge from hospital following birth
Secondary outcome [19] 349754 0
Cause of perinatal deaths - data derived from hospital records
Timepoint [19] 349754 0
At discharge from hospital following birth
Secondary outcome [20] 349755 0
Antenatal exclusive breastfeeding intention (Yes/No)- data derived from hospital records
Timepoint [20] 349755 0
Prior to birth
Secondary outcome [21] 349756 0
Women exclusively feeding at breast at discharge from hospital following birth (Yes/No; also Primary outcome), at 2 months postnatal (Yes/No) and 6 months postnatal (Yes/No)- data derived from hospital records and survey designed for this study
Timepoint [21] 349756 0
Birth, 2 and 6 months postnatal
Secondary outcome [22] 349757 0
Infant readmission to hospital up to 6 months of age (Yes/No)- data derive from hospital records and survey designed for this study
Timepoint [22] 349757 0
6 months postpartum
Secondary outcome [23] 349758 0
Length of stay in hospital for mothers and infants following birth (Mean, Median, Range) -data derived from hospital records
Timepoint [23] 349758 0
At discharge from hospital following birth
Secondary outcome [24] 349759 0
Cost of care per mother/infant pair during pregnancy, birth, and postnatal until mother 6 weeks postpartum and baby 28 days after birth (DRG and ICD code for hospital admissions) -data derived from hospital records
Timepoint [24] 349759 0
6 weeks postnatal
Secondary outcome [25] 349760 0
Negative life events scale - full extended version
Timepoint [25] 349760 0
Booking, 6 months postnatal
Secondary outcome [26] 350528 0
Modified Kessler Psychological Distress Scale (K5) score
Timepoint [26] 350528 0
Booking, 36 weeks gestation, 2 & 6 months postnatal
Secondary outcome [27] 350531 0
Edinburgh Postnatal Depression Scale score
Timepoint [27] 350531 0
Booking, 6 months postnatal
Secondary outcome [28] 350532 0
Ages and Stages Questionnaire score
Timepoint [28] 350532 0
2 and 6 months postnatal
Secondary outcome [29] 350533 0
Bayley III Cognitive, Language and Motor Skills
Timepoint [29] 350533 0
six months postnatal
Secondary outcome [30] 351259 0
Mother readmission to hospital up to 6 months postpartum (Yes/No)- data derive from hospital records and survey designed for this study
Timepoint [30] 351259 0
6 months postpartum

Eligibility
Key inclusion criteria
Women’s surveys, Tell My Story and Infant Assessments: Women are eligible to participate if they:
• Identify as Aboriginal and/or Torres Strait Islander, or identify their baby as Aboriginal and/or Torres Strait Islander person;
• Receive their maternity care through the Birthing in Our Community Program and are planning to birth at the MMH (Group 1); receive their maternity care through the Ngarrama Indigenous Maternity Service and are planning to birth at the RBWH (Group 4); receive standard maternity care and birth at the MMH or RBWH (Groups 2 & 5) and
• Consent to participate.

Infants are eligible if:
• They are Aboriginal and Torres Strait Islander babies and their mothers received care through either of these programs and were recruited to the study.


Staff are eligible to participate in the staff surveys, interviews and focus groups if they have been involved in the planning and/or provision of maternity care services for Aboriginal and Torres Strait Islander families in South East Queensland during the study period; and consent to participate.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women are not eligible to participate if they:
• Have been transferred into the RBWH or the MMH from out of area for high-level specialist services or received no antenatal care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is no allocation concealment, both women and care providers are aware of their model of care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Some participants receive parallel assignment (self- selected or allocated depending on available spaces but there is also historical control groups.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative analyses will compare the difference in clinical outcomes between Birthing in Our Community (intervention), the Ngarrama Service (concurrent control), standard care (historical and concurrent control), and also non-Indigenous women and babies (historical and concurrent control) at MMH and RBWH.

This study has been powered to detect changes in clinical outcomes. During the 3.5 year recruitment period, we will aim to access routinely collected data for approximately 420 women at MMH, and 350 from RBWH (based on an estimated 20% attrition rate). The change in outcomes has been estimated based on changes seen in the Townsville Mums and Bubs program that reported a reduction in preterm birth.

Initial bivariate analysis will investigate possible differences between the cohorts for baseline socio-demographic (socio-economic status), and clinical characteristics (e.g. age, parity, BMI, smoking, obstetric history) that could affect outcome measures. Dependent on data type, analysis will be undertaken using an independent samples t-test, Mann-Whitney U test or chi-squared test. Outcome measures will be presented using relative risks with 95% confidence intervals. Multivariate logistic, linear regression models and propensity score matching will be used to adjust for confounders. Longitudinal outcomes (e.g. breastfeeding) will be analysed with generalized estimating equations to account for the correlation between observations repeated in the same person. To understand the mechanism or process that underlies the effect of model of care on outcomes, mediation analysis will be conducted to identify if and to what extent the other variables explains the relationship. All withdrawals, losses to follow-up, and deaths will be reported. Analysis will be performed with SPSS Version 22.0/Stata 14.0 and statistical significance will be at the 0.05 level.

The cost-effectiveness analysis will be conducted to examine the direct costs, from a societal perspective, to women and their families, maternity and child health care services and other community services in relation to pregnancy and birth. We will compare the mean costs per mother/infant pair between Birthing in Our Community (Group 1) and the Ngarrama Service (Group 4) to standard care group (Group 2 and 5) up to six weeks postpartum. Costs will be calculated for both mother and baby to include: women and family’s out-of-pocket expenses related to clinic appointments, outpatients (ultrasound, pathology, etc.) and prescribed medicines, and hospitalisation costs. Data will be collected through routinely collected information as well as questions embedded in the 36 week antenatal and two month postnatal surveys. Average costs for each mother and infant for the duration of the maternity episode (i.e. from when she first confirmed her pregnancy to six weeks postnatal) will be calculated and compared to determine the cost effectiveness of a model of care.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/10/2015
Date of last participant enrolment
Anticipated
30/04/2019
Actual
18/01/2019
Date of last data collection
Anticipated
31/12/2019
Actual
31/12/2019
Sample size
Target
770
Accrual to date
Final
618
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11243 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [2] 11244 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 23119 0
4101 - South Brisbane
Recruitment postcode(s) [2] 23120 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 299917 0
Government body
Name [1] 299917 0
National Health and Medical Research Council
Country [1] 299917 0
Australia
Funding source category [2] 299925 0
Hospital
Name [2] 299925 0
Mater Mothers Hospital
Country [2] 299925 0
Australia
Funding source category [3] 299926 0
Commercial sector/Industry
Name [3] 299926 0
Institute for Urban Indigenous Health
Country [3] 299926 0
Australia
Funding source category [4] 299927 0
Commercial sector/Industry
Name [4] 299927 0
Aboriginal and Torres Strait Islander Community Health Service Brisbane Limited
Country [4] 299927 0
Australia
Funding source category [5] 299928 0
Government body
Name [5] 299928 0
Queensland Health
Country [5] 299928 0
Australia
Primary sponsor type
Individual
Name
Prof Sue Kildea
Address
Mater Research
Level 1, Aubigny Place, South Brisbane, Qld 4101
Country
Australia
Secondary sponsor category [1] 299284 0
Individual
Name [1] 299284 0
Prof Sue Kruske
Address [1] 299284 0
Institute for Urban Indigenous Health
22 Cox Rd, Windsor, Qld 4030
Country [1] 299284 0
Australia
Secondary sponsor category [2] 299293 0
Individual
Name [2] 299293 0
A/Prof Megan Passey
Address [2] 299293 0
University Centre for Rural Health, University of Sydney
61 Uralba St, Lismore, NSW 2480
Country [2] 299293 0
Australia
Secondary sponsor category [3] 299294 0
Individual
Name [3] 299294 0
Prof Sally Tracy
Address [3] 299294 0
The University of Sydney
88 Mallett Street - Building A
Camperdown NSW 2050
Country [3] 299294 0
Australia
Secondary sponsor category [4] 299299 0
Individual
Name [4] 299299 0
Dr Anton Clifford
Address [4] 299299 0
Mater Research
Aubigny Place, Raymond Tce, Qld 4101
Country [4] 299299 0
Australia
Secondary sponsor category [5] 299300 0
Individual
Name [5] 299300 0
A/Prof Carmel Nelson
Address [5] 299300 0
Institute for Urban Indigenous Health
22 Cox Rd, Windsor, Qld 4030
Country [5] 299300 0
Australia
Secondary sponsor category [6] 299301 0
Individual
Name [6] 299301 0
Dr Yvette Roe
Address [6] 299301 0
Mater Research
Aubigny Place, Raymond Tce, South Brisbane, Qld 4101
Country [6] 299301 0
Australia
Secondary sponsor category [7] 299302 0
Individual
Name [7] 299302 0
Prof Roianne West
Address [7] 299302 0
First Peoples Health Unit, Griffith University
Parklands Dr, Southport QLD 4215
Country [7] 299302 0
Australia
Other collaborator category [1] 280201 0
Individual
Name [1] 280201 0
Renee Blackman
Address [1] 280201 0
Aboriginal and Torres Strait Islander Community Health Service Brisbane Ltd
55 Annerley Rd, Woolloongabba, Qld 4102
Country [1] 280201 0
Australia
Other collaborator category [2] 280202 0
Individual
Name [2] 280202 0
Jody Currie
Address [2] 280202 0
Aboriginal and Torres Strait Islander Community Health Service Brisbane Ltd
55 Annerley Rd, Woolloongabba, Qld 4102
Country [2] 280202 0
Australia
Other collaborator category [3] 280203 0
Individual
Name [3] 280203 0
Adrian Carson
Address [3] 280203 0
Institute for Urban Indigenous Health
22 Cox Rd, Windsor, Qld 4030
Country [3] 280203 0
Australia
Other collaborator category [4] 280204 0
Individual
Name [4] 280204 0
Machellee Kosiak
Address [4] 280204 0
Australian Catholic University
1100 Nudgee Rd, Banyo QLD 4014
Country [4] 280204 0
Australia
Other collaborator category [5] 280205 0
Individual
Name [5] 280205 0
Shannon Watego
Address [5] 280205 0
Mater Misericordiae Limited
Raymond Tce, South Brisbane, Qld 4101
Country [5] 280205 0
Australia
Other collaborator category [6] 280206 0
Individual
Name [6] 280206 0
Kay Wilson
Address [6] 280206 0
Mater Misericordiae Limited
Raymond Tce, South Brisbane, Qld 4101
Country [6] 280206 0
Australia
Other collaborator category [7] 280207 0
Individual
Name [7] 280207 0
Prof Joan Webster
Address [7] 280207 0
Nursing and Midwifery Research Centre, Level 2, Bld 34, RBWH, Butterfield Street, Herston, Qld 4029
Country [7] 280207 0
Australia
Other collaborator category [8] 280281 0
Individual
Name [8] 280281 0
Cameron Hurst
Address [8] 280281 0
Queensland Institute of Medical Research Berghofer
300 Herston Rd, Brisbane City QLD 4006
Country [8] 280281 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300786 0
Mater Misericordiae Limited Human Research Ethics Committee
Ethics committee address [1] 300786 0
Ethics committee country [1] 300786 0
Australia
Date submitted for ethics approval [1] 300786 0
02/03/2015
Approval date [1] 300786 0
15/04/2015
Ethics approval number [1] 300786 0
HREC/15/MHS/24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84814 0
Prof Sue Kildea
Address 84814 0
CDU, 410 Ann St, East Tower Level 11, Brisbane Q 4000
Country 84814 0
Australia
Phone 84814 0
+61 7 3163 6388
Fax 84814 0
Email 84814 0
sue.kildea@mater.uq.edu.au
Contact person for public queries
Name 84815 0
Sue Kildea
Address 84815 0
CDU, 410 Ann St, East Tower Level 11, Brisbane City QLD 4000
Country 84815 0
Australia
Phone 84815 0
+61 7 3163 6388
Fax 84815 0
Email 84815 0
sue.kildea@cdu.edu.au
Contact person for scientific queries
Name 84816 0
Sue Kildea
Address 84816 0
CDU, 410 Ann St, East Tower, Brisbane QLD 4000
Country 84816 0
Australia
Phone 84816 0
+61 7 3163 6388
Fax 84816 0
Email 84816 0
sue.kildea@cdu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified quantitative data
When will data be available (start and end dates)?
2022-2025
Available to whom?
Case-by-case basis at the discretion of Chief Investigator and Steering Committee
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
The datasets generated and/or analysed during the current study may be
available from the Chief Investigator (sue.kildea@cdu.edu.au) on reasonable request pending
approval by the Birthing in Our Community Steering Committee to ensure
Indigenous data sovereignty guidelines are adhered to.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16096Study protocolHickey, S., Roe, Y., Gao, Y. et al. The Indigenous Birthing in an Urban Setting study: the IBUS study. BMC Pregnancy Childbirth 18, 431 (2018). https://doi.org/10.1186/s12884-018-2067-8https://doi.org/10.1186/s12884-018-2067-8 
16097Statistical analysis plan  sue.kildea@cdu.edu.au
16098Informed consent form  sue.kildea@cdu.edu.au
16099Ethical approvalHREC/15/MHS/24  



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Indigenous Birthing in an Urban Setting study: the IBUS study2018https://doi.org/10.1186/s12884-018-2067-8
N.B. These documents automatically identified may not have been verified by the study sponsor.