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The TEXT-Bone Substudy investigates serial bone markers for bone remodeling, serial growth factors, and bone mineral density for TEXT patients in selected centers.
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The TEXT-Bone Substudy investigates serial bone markers for bone remodeling, serial growth factors, and bone mineral density for TEXT patients in selected centers.
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Protocol v2.0 Amendment 1<\/a> (February 1, 2011)<\/li>\r\n
Reasons for Amendment 1<\/a> (February 1, 2011)<\/li>\r\n
Signature Page<\/a> (version September 17, 2008)<\/li>\r\n
Appendix 1b: Patient Informatin and Informed Consent (Feb 2011)\r\n
\r\n
English<\/a><\/li>\r\n
Flemish<\/a><\/li>\r\n
French<\/a><\/li>\r\n
German<\/a><\/li>\r\n
Italian<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n
Appendix II<\/a>: Group Logistics (version 1.0, October 7, 2008)<\/li>\r\n
Amendment cover letter:\r\n
\r\n
Belgium<\/a><\/li>\r\n
Italy<\/a><\/li>\r\n
Switzerland<\/a><\/li>\r\n
other Countries<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n
BMD and Serum Manual <\/a>(version 3.0, September 15, 2011)<\/li>\r\n
Serum Specimen Shipping Form<\/a> (doc file, version 3.0, September 05, 2011)<\/li>\r\n
Serum Kit Resupply Form<\/a><\/li>\r\n
Data Managers Manual <\/a>(version 2.0, March 2011)<\/li>\r\n
Patient CRF Packet (A4):\r\n
\r\n
English<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n
Patient CRF Packet (Letter):\r\n
\r\n
English<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","field53":"33"},"row1":{"field51":"Current Status","field52":"
- Current Accrual:<\/p>\r\n
\r\n
Closure Letter<\/a><\/li>\r\n
Final Accrual TEXT-Bone Substudy<\/a><\/li>\r\n<\/ul>\r\n
- Biostatisticians' Reports:<\/p>\r\n
\r\n
Trial 24-02 (SOFT) and Trial 25-02 (TEXT) Biostatisticians' Report 2014
<\/a>(combined report) incl Biostatisticians' Reports Co-SOFT Substudy, SOFT-EST Substudy and TEXT-Bone Substudy<\/li>\r\n<\/ul>\r\n
- IBCSG EC Statements<\/p>\r\n
\r\n
April 23, 2012<\/a><\/li>\r\n
March 19, 2011<\/a><\/li>\r\n
February 18, 2011<\/a><\/li>\r\n
March 25, 2010<\/a><\/li>\r\n
March 14, 2009<\/a><\/li>\r\n
September 30, 2008<\/a><\/li>\r\n<\/ul>","field53":"33"},"row2":{"field51":"Data Management Resources","field52":"
General Resources<\/h2>\r\n
\r\n
{loadposition dfexplore}<\/p>\r\n<\/div>\r\n
\r\n
{loadposition reg-rando-manual}<\/p>\r\n<\/div>","field53":"33"}}"
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Documents

Protocol v2.0 Amendment 1 (February 1, 2011)
Reasons for Amendment 1 (February 1, 2011)
Signature Page (version September 17, 2008)
Appendix 1b: Patient Informatin and Informed Consent (Feb 2011)

English
Flemish
French
German
Italian


Appendix II: Group Logistics (version 1.0, October 7, 2008)
Amendment cover letter:

Belgium
Italy
Switzerland
other Countries


BMD and Serum Manual (version 3.0, September 15, 2011)
Serum Specimen Shipping Form (doc file, version 3.0, September 05, 2011)
Serum Kit Resupply Form
Data Managers Manual (version 2.0, March 2011)
Patient CRF Packet (A4):

English


Patient CRF Packet (Letter):

English


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Documents

Protocol v2.0 Amendment 1 (February 1, 2011)
Reasons for Amendment 1 (February 1, 2011)
Signature Page (version September 17, 2008)
Appendix 1b: Patient Informatin and Informed Consent (Feb 2011)

English
Flemish
French
German
Italian


Appendix II: Group Logistics (version 1.0, October 7, 2008)
Amendment cover letter:

Belgium
Italy
Switzerland
other Countries


BMD and Serum Manual (version 3.0, September 15, 2011)
Serum Specimen Shipping Form (doc file, version 3.0, September 05, 2011)
Serum Kit Resupply Form
Data Managers Manual (version 2.0, March 2011)
Patient CRF Packet (A4):

English


Patient CRF Packet (Letter):

English


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DFexplore System:

DFexplore Center User Manual v.2.0
DFexplore User Manual for View-Only Access v2.0
DFexplore Study Monitor Instructions for Source Data Verification (SDV) v7.0
DFexplore Fax Numbers
DF Support Web Application








        

    

Registration/Randomization Procedures Manual (v6.0, March 2021)



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      string(0) ""
      ["display"]=>
      string(1) "3"
      ["layout"]=>
      string(0) ""
      ["display_readonly"]=>
      string(1) "2"
    }
    ["initialized":protected]=>
    bool(true)
    ["separator":protected]=>
    string(1) "."
  }
  ["type"]=>
  string(6) "editor"
  ["default_value"]=>
  string(0) ""
  ["context"]=>
  string(19) "com_content.article"
  ["group_id"]=>
  int(2)
  ["label"]=>
  string(5) "aside"
  ["description"]=>
  string(0) ""
  ["required"]=>
  int(0)
  ["only_use_in_subform"]=>
  int(0)
  ["language_title"]=>
  NULL
  ["language_image"]=>
  NULL
  ["editor"]=>
  NULL
  ["access_level"]=>
  string(6) "Public"
  ["author_name"]=>
  string(4) "artd"
  ["group_title"]=>
  string(5) "trial"
  ["group_access"]=>
  int(1)
  ["group_state"]=>
  int(1)
  ["group_note"]=>
  string(0) ""
  ["value"]=>
  string(140) "
Date of Closure
December 31, 2012
"
  ["rawvalue"]=>
  string(140) "
Date of Closure
December 31, 2012
"
}