Protocol summary
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Study aim
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To determine the effect of Acceptance and Commitment Therapy on changing the decision of pregnant women seeking abortion to continue their pregnancy, acceptance of the maternal role, and adaptation to pregnancy.
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Design
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This is a randomized controlled clinical trial with two parallel groups and no blinding, with an anticipated sample size of 112 participants (56 per group). Participants will be allocated using block randomization with blocks of six and a 1:1 allocation ratio. The randomization sequence will be generated by an independent individual, and allocation will be concealed using opaque, sealed, sequentially numbered envelopes. Study phase: Not applicable.
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Settings and conduct
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This randomized controlled clinical trial will be conducted at the Nafas Center in Ahvaz. After obtaining informed consent, participants will be randomly allocated to the intervention and control groups. The intervention group will receive 8 weekly 90-minute sessions of acceptance and commitment therapy (ACT)-based education, while the control group will receive routine services provided by the center. This study will be conducted without blinding.
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Participants/Inclusion and exclusion criteria
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Inclusion: Women 18–48y, 4–20wks gestation, intrauterine pregnancy, Persian literacy, consent; Exclusion: acute psych/med/obstetric conditions, pregnancy/fetal complications, substance abuse, major stressors, concurrent psychotherapy, incomplete data.
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Intervention groups
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Intervention group: Group-based acceptance and commitment therapy (ACT) education will be provided in 8 weekly 90-minute sessions, delivered in 6 groups. The control group will receive routine services at the Nafas Center in Ahvaz, including routine prenatal care and psychosocial support, and will not receive the ACT intervention.
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Main outcome variables
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Change in the decision to continue pregnancy; acceptance of the maternal role; adaptation to pregnancy
General information
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Reason for update
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Due to a technical issue with the IRCT system, the registration and approval process of the study was delayed. As a result, the participant recruitment start date entered when initially completing the registration form does not correspond to the final approval date of the study.
Since participant recruitment has not yet started, I would like to correct the participant recruitment start date registered in the system so that it accurately reflects the actual status of the study and is consistent with the approval date of the clinical trial.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20260719070262N1
Registration date:
2026-09-18, 1405/06/27
Registration timing:
prospective
Last update:
2026-09-27, 1405/07/05
Update count:
1
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Registration date
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2026-09-18, 1405/06/27
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2026-10-10, 1405/07/18
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Expected recruitment end date
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2027-01-20, 1405/10/30
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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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Investigating the effect of acceptance and commitment therapy on changing the decision of pregnant women seeking abortion to continue their pregnancy, acceptance of the maternal role and adaptation to pregnancy
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Public title
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The Effect of an Acceptance and Commitment Therapy-Based Counseling Program on the Decision to Continue Pregnancy and Psychological Adaptation to Pregnancy among Pregnant Women Seeking Abortion
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women of reproductive age aged 18 to 48 years
gestational age of 4 to 20 weeks
confirmed intrauterine pregnancy
literacy in reading and writing in Persian
provision of written informed consent
Exclusion criteria:
Presence of acute psychiatric disorders
Presence of medical or obstetric complications
Presence of acute pregnancy complications, such as bleeding or threatened abortion
Fetal abnormalities
Addiction to alcohol, illicit drugs, or other psychotropic substances
Occurrence of significant stressful life events, such as the death of a spouse or a family member
Concurrent participation in a similar psychotherapy program
Failure to complete the study questionnaires
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Age
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From 18 years old to 48 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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No information
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Sample size
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Target sample size:
112
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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 allocated to two groups using block randomization with blocks of six and a 1:1 allocation ratio: an acceptance and commitment therapy-based counseling group (n = 56) and a control group (n = 56). The randomization sequence will be generated using blocks of six by an individual independent of the research team. To ensure allocation concealment, each allocation will be placed separately in an opaque, sealed, light-proof, sequentially numbered envelope, with only one allocation code (A or B) inside each envelope. After eligibility criteria have been confirmed and informed consent has been obtained, the next envelope will be opened in sequential numerical order, and the participant will be assigned to either the intervention or control group according to the allocation code contained in the envelope.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2026-07-25, 1405/05/03
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Ethics committee reference number
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IR.AJUMS.REC.1405.189
Health conditions studied
1
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Description of health condition studied
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unwanted pregnancy
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ICD-10 code
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Z64.0
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ICD-10 code description
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Problems related to unwanted pregnancy
Primary outcomes
1
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Description
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Score of change in the decision of pregnant women seeking abortion to continue the pregnancy and acceptance of pregnancy based on the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ)
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Timepoint
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Measurement of the score of change in the decision of pregnant women seeking abortion to continue the pregnancy and acceptance of pregnancy using the Lederman Prenatal Self-Evaluation Questionnaire (PSEQ) at baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and one month after the end of the intervention (follow-up).
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
Secondary outcomes
1
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Description
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Maternal role acceptance (maternal role identification) score based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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Measurement of the score of maternal role acceptance (identification with the maternal role) using the Lederman Prenatal Self-Evaluation Questionnaire at baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and one month after the end of the intervention (follow-up).
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
2
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Description
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Score of relationship with the partner based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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Measurement of the score of relationship with the partner using the Lederman Prenatal Self-Evaluation Questionnaire at baseline (pre-test), immediately after completion of the 8 intervention sessions (post-test), and one month after the end of the intervention (follow-up).
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
3
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Description
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Score of preparation for childbirth based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
4
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Description
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Score of sense of control during the childbirth process based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
5
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Description
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Score of well-being of self and baby based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
6
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Description
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Score of relationship with mother based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
7
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Description
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Score of adaptation to pregnancy based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of the intervention.
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
8
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Description
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Score of psychological adaptation to pregnancy based on the Lederman Prenatal Self-Evaluation Questionnaire
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Timepoint
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At baseline (before the start of the intervention), immediately after completion of the 8 intervention sessions, and one month after the end of
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Method of measurement
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Lederman Prenatal Self-Evaluation Questionnaire
Intervention groups
1
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Description
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Intervention group: Group-based Acceptance and Commitment Therapy (ACT) delivered in 8 weekly 90-minute sessions, conducted in 6 groups of 8–9 participants, aiming to improve psychological adaptation to pregnancy, maternal role acceptance, and decision-making regarding continuation of pregnancy. The sessions will cover introduction to ACT, acceptance, cognitive defusion, self-as-context, present-moment awareness, values, and committed action.
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Category
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Treatment - Other
2
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Description
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Control group: Participants will receive routine services provided by Nafas Center, including routine prenatal care and usual psychosocial support. The control group will not receive ACT during the study.
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Category
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Treatment - Other
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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Ahvaz 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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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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Due to the need to maintain the confidentiality of participants' information and the limitations arising from informed consent and ethical considerations of the study, de-identified individual participant data will not be shared with other researchers.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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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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Not applicable
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available