Form:DrugProjectForm01: Difference between revisions

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Gerald Chi (talk | contribs)
CMEAdmin, Bureaucrats, bureaucrats, editnews, exportpages, interwiki, nocaptcha, nukepages, smwadministrator, Administrators, Widget editors
17,702 edits
mNo edit summary
Line 103: Line 103:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter the '''adverse reactions''' provided in the "Clinical Trials Experience" section:
* Please enter the '''adverse reactions''' provided in the "Clinical Trials Experience" section:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|clinicalTrials|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|clinicalTrials|input type=textarea|default=There is limited information regarding ''Clinical Trials Experience'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter the '''adverse reactions''' provided in the "Postmarketing Experience" section:
* Please enter the '''adverse reactions''' provided in the "Postmarketing Experience" section:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|postmarketing|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|postmarketing|input type=textarea|default=There is limited information regarding ''Postmarketing Experience'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Drug Interactions
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Drug Interactions
Line 123: Line 123:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug '''during labor and delivery''':
* Please enter information related to the use of the drug '''during labor and delivery''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInLaborDelivery|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInLaborDelivery|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} during labor and delivery.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug '''during nursing''':
* Please enter information related to the use of the drug '''during nursing''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInNursing|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInNursing|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug in '''pediatrics''':
* Please enter information related to the use of the drug in '''pediatrics''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInPed|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInPed|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug in '''geriatrics''':
* Please enter information related to the use of the drug in '''geriatrics''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInGeri|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInGeri|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug and '''gender''':
* Please enter information related to the use of the drug and '''gender''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInGender|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInGender|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug and '''race''':
* Please enter information related to the use of the drug and '''race''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInRace|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInRace|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug in patients with '''renal impairment''':
* Please enter information related to the use of the drug in patients with '''renal impairment''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInRenalImpair|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInRenalImpair|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug in patients with '''hepatic impairment''':
* Please enter information related to the use of the drug in patients with '''hepatic impairment''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInHepaticImpair|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInHepaticImpair|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug in '''females of reproductive potential and males''':
* Please enter information related to the use of the drug in '''females of reproductive potential and males''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInReproPotential|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInReproPotential|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the use of the drug in '''immunocompromised patients''':
* Please enter information related to the use of the drug in '''immunocompromised patients''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInImmunocomp|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|useInImmunocomp|input type=textarea|default=There is no FDA guidance on the use of {{PAGENAME}} in patients who are immunocompromised.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
Line 173: Line 173:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information pertaining to the '''monitoring''' here:
* Please enter information pertaining to the '''monitoring''' here:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|monitoring|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|monitoring|input type=textarea|default=There is limited information regarding ''Monitoring'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Overdose
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Overdose
Line 196: Line 196:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the '''structure''':
* Please enter information related to the '''structure''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|structure|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|structure|input type=textarea|default=
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the '''pharmacodynamics''':
* Please enter information related to the '''pharmacodynamics''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|PD|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|PD|input type=textarea|default=There is limited information regarding ''Pharmacodynamics'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the '''pharmacokinetics''':
* Please enter information related to the '''pharmacokinetics''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|PK|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|PK|input type=textarea|default=There is limited information regarding ''Pharmacokinetics'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information related to the '''nonclinical toxicology''':
* Please enter information related to the '''nonclinical toxicology''':
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|nonClinToxic|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|nonClinToxic|input type=textarea|default=There is limited information regarding ''Nonclinical Toxicology'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Clinical Studies
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Clinical Studies
Line 214: Line 215:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information pertaining to the '''clinical studies''' of the drug:
* Please enter information pertaining to the '''clinical studies''' of the drug:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|clinicalStudies|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|clinicalStudies|input type=textarea|default=There is limited information regarding ''Clinical Studies'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | How Supplied
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | How Supplied
|-
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter information pertaining to '''how the drug is supplied''':
* Please enter information pertaining to '''how the drug is supplied''':
Line 231: Line 231:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter the '''Patient Counseling Information''' here:
* Please enter the '''Patient Counseling Information''' here:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|fdaPatientInfo|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|fdaPatientInfo|input type=textarea|default=There is limited information regarding ''Patient Counseling Information'' of {{PAGENAME}} in the drug label.}}}
|-
|-
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Precautions with Alcohol
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Precautions with Alcohol
Line 243: Line 243:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter the '''brand names''' here:
* Please enter the '''brand names''' here:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|brandNames|input type=textarea}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|brandNames|input type=textarea|default=®}}}
 
|-
|-
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Look-Alike Drug Names
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Look-Alike Drug Names
Line 249: Line 250:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter '''look-alike names''' that could be confused with the drug:
* Please enter '''look-alike names''' that could be confused with the drug:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|lookAlike|input type=textarea}}}{{{end template}}}
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|lookAlike|input type=textarea|default=A® — B®}}}
|}
|-
 
| style="font-weight: bold; font-size: 150%; padding: 5px 15px; background: #545454; border-radius: 5px 5px 5px 5px; text-shadow: 0 -1px 0 rgba(0, 0, 0, 0.5); box-shadow: 0 1px 1px rgba(0, 0, 0, 0.5); color: #F8F8FF;" colspan=2 | Package and Label Display Panel
|-
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top |
* Please enter the '''Package and Label Display Panel''' here:
| style="width: 1000px; padding: 5px 5px; border: 2px solid #999; border-radius: 5px 5px 5px 5px;" valign=top | {{{field|brandNames|input type=textarea|default=
 
: [[File:{{PAGENAME}}11.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}12.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}13.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]}}}
 
|-
|}{{{end template}}}
 
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{{{standard input|save}}} {{{standard input|preview}}} {{{standard input|changes}}} {{{standard input|cancel}}}
{{{standard input|save}}} {{{standard input|preview}}} {{{standard input|changes}}} {{{standard input|cancel}}}
</includeonly>
</includeonly>

Revision as of 02:31, 31 January 2015

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