Protocol summary
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Study aim
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Determining the effect of probiotic administration to mothers with low birth weight neonates on some of the neonatal and maternal outcomes
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Design
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Randomized, superiority, placebo-controlled, double-blind trial with two parallel arms: 122 participants will be equally randomized into the groups using stratified block randomization referring to a computerized program
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Settings and conduct
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In Al-Zahra teaching hospitals in Tabriz, eligible infants and their mothers will be studied after receiving informed written consent from the mothers and if possible from fathers. The participants, those administering the interventions, care providers, and those collecting and analyzing data will be blinded.
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Participants/Inclusion and exclusion criteria
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Participants will be mothers with low birth weight (1000 to 2000 g) infants. The mothers should have given birth in the past 48 h, have the desire and ability to breastfeed, and be able to attend the hospital at least once a week. The infants should be hospitalized for at least 7 days after starting the intervention. Exclusion criteria include triplets or more, infant's bad condition, contraindications to breastfeeding, the existence of obvious anomalies in the neonate, regular use of probiotics (in any form) by the mother, history of probiotic allergy or existence of immunity disorders in the mother, and unwillingness to participate in the study.
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Intervention groups
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Mothers will receive probiotic supplement in the intervention group and placebo in the control group, one capsule a day for 6 weeks.
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Main outcome variables
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Level of total serum bilirubin in the neonate at the fourth and seventh days of intervention, and postpartum depression (40-45 days of the intervention)
General information
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Reason for update
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Due to the challenge of finding mothers with infants weighting between 1000 and 1500 g and the extended sampling period, the Research Council approved an expansion of the infant weight range to 1000 to 2000 g. Additionally, it was determined that stratified allocation based on infant birth weight (1000 to 1500 g and 1501 to 2000 g) would be implemented, along with consideration of the previous stratified factor of number of fetuses (singleton/twin).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100414003706N42
Registration date:
2022-11-22, 1401/09/01
Registration timing:
prospective
Last update:
2024-02-04, 1402/11/15
Update count:
1
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Registration date
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2022-11-22, 1401/09/01
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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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2022-12-22, 1401/10/01
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Expected recruitment end date
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2023-09-22, 1402/06/31
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Actual recruitment start date
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2022-12-30, 1401/10/09
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Actual recruitment end date
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2023-10-31, 1402/08/09
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Trial completion date
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2023-11-15, 1402/08/24
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Scientific title
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The effect of probiotic administration to mothers with low birth weight neonates on some of the neonatal and maternal outcomes
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Public title
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The effect of probiotic administration to mothers with low birth weight neonates
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Neonatal birth weight of 1000 to 2000 g
Delivery in the past 48 h
Hospitalization of the infant for at least 7 days after the start of the intervention
Possibility of the mother to attend the hospital where the baby is admitted, at least once a week
Desire and ability to breastfeed her baby
Exclusion criteria:
Triplets or more
Bad condition of the infant diagnosed by a neonatologist
contraindications for feeding the infant with breast milk
Existence of obvious anomalies in the neonate
Regular use of probiotics (in any form) by the mother
History of sensitivity to probiotics in the mother
Immunodeficiency in the mother
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
122
Actual sample size reached:
122
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be individually randomized into intervention or control groups using stratified (single/twin pregnancy and infant birth weight (1000-15000/1501-2000)) block randomization with a block size of four and a ratio of 1:1. Allocation sequence will be generated using a computerized program. Identical sequentially numbered bottles containing probiotic or placebo capsules will be used to conceal the sequence and enable blinding.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Probiotic supplements and placebo will be prepared in identical shapes, colors, smells, and packages. The sequence generation and preparation of the packs will be done by a person not involved in participant recruitment or data collection. Identical sequentially numbered bottles containing probiotic or placebo capsules will be used to conceal the allocation sequence and enable blinding. The persons administering the interventions, health care providers, outcome assessors, and statistical analysts will be blinded.
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Placebo
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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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2022-11-14, 1401/08/23
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Ethics committee reference number
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IR.TBZMED.REC.1401.735
Health conditions studied
1
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Description of health condition studied
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Hyperbilirubinemia (Jaundice)
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ICD-10 code
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P59.9
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ICD-10 code description
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Neonatal jaundice, unspecified
2
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Description of health condition studied
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Postpartum depression
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ICD-10 code
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F32.8
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ICD-10 code description
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Other depressive episodes
3
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Description of health condition studied
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Mastitis
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ICD-10 code
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O91.22
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ICD-10 code description
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Nonpurulent mastitis associated with the puerperium
Primary outcomes
1
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Description
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Total serum bilirubin level in newborn
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Timepoint
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The fourth and seventh days of intervention
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Method of measurement
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laboratory assessment
2
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Description
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Postpartum depression
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Timepoint
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Baseline, 40-45 days after birth
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Method of measurement
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The Edinburgh Postpartum Depression Scale
Secondary outcomes
1
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Description
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Infant weight gain during 40-45 days
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Timepoint
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At baseline, 7th day of the intervention, discharge day, and 40 to 45 days after birth
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Method of measurement
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Using a digital scale
2
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Description
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Total duration of phototherapy (hours)
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Timepoint
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During neonatal period
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Method of measurement
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Daily assessment of infant medical record
3
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Description
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Duration of infant hospitalization
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Timepoint
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Until discharge from the hospital (if discharged earlier than 40 - 45 days, assessment after 40 -45 days for re-admission to hospital)
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Method of measurement
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Assessment of infant medical record and contact with the mother after 40 - 45 days in case of early discharge
4
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Description
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The composite variable of occurrence of serious neonatal problems (including bronchopulmonary dysplasia, sepsis, necrotizing enterocolitis, or retinopathy of prematurity)
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Timepoint
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40- 45 days of infancy
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Method of measurement
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Diagnosed by a neonatologist and an ophthalmologist based on clinical and para-clinical assessments (Retinopathy of prematurity will be assessed by an ophthalmologist after 28 days of infancy) which is recorded in the medical records.
5
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Description
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Occurrence of mastitis in the mother
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Timepoint
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During 40 -45 days of childbirth
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Method of measurement
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Using the Mastitis scale
6
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Description
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Postpartum anxiety
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Timepoint
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40-45 days after birth
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Method of measurement
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Specific Postpartum Anxiety Scale
Intervention groups
1
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Description
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Intervention group: capsules of the probiotic supplement containing CFU/g 3×109 Lacticaseibacillus paracasei subsp. Paracasei and Bifidobacterium lactis (animals) will be given once a day for 6 weeks to the mothers.
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Category
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Prevention
2
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Description
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Control group: placebo capsules containing starch powder will be given once a day for 6 weeks to the mothers.
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Category
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Placebo
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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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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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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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The requested data will be provided to researchers for statistical analysis (meta-analysis) of the submitted proposal.
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When the data will become available and for how long
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starting immediately after the publication of the study results
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To whom data/document is available
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Data will be available to researchers working at academic organizations, as well as to the chief editor (and reviewers) of the journal of the submitted manuscript/s if requested.
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Under which criteria data/document could be used
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The data will be available to researchers upon request and submission of a proposal to perform a meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to the journal of submitted manuscript/s for checking the accuracy of the data
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From where data/document is obtainable
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Refer to the email address (alizades@tbzmed.ac.ir; mhammadalizadehs@gmail.com)
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What processes are involved for a request to access data/document
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The requests will be sent by email and data will be available within two weeks.
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Comments
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