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SUPPRELIN LA is a sterile, non-biodegradable, diffusion-controlled, hydrogel polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH) possessing a greater potency than the natural sequence hormone. SUPPRELIN LA is designed to deliver approximately 65 mcg histrelin acetate per day over 12 months.
The SUPPRELIN LA implant looks like a small thin flexible tube and consists of a 50-mg histrelin acetate drug core inside a 3.5 cm by 3 mm, cylindrical, hydrogel polymer reservoir (Figure 1).
Figure 1: SUPPRELIN LA Implant Diagram (not to scale)
The chemical name of histrelin acetate is: L-Pyroglutamyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-N-benzyl- D-histidyl-L-leucyl-L-arginyl-L-proline N-ethylamide, acetate salt.
The molecular formula for histrelin acetate is C66H86N18O12 x 2CH3COOH and its molecular weight is 1443.70 (or 1323.52 as free base). Histrelin is also chemically described as 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-Lseryl- L-tyrosyl-Nt-benzyl-D-histidyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide diacetate. The chemical structure of the free base (histrelin) is represented below in Figure 2.
Figure 2: Structure of Histrelin
The drug core also contains the inactive ingredient stearic acid NF. The hydrogel polymer reservoir is a hydrophilic cartridge composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100. Each implant is packaged hydrated in a glass vial containing 2 mL of sterile 1.8% sodium chloride solution, so that it is primed for immediate release of the drug upon insertion.
A single use, sterile, Insertion Tool is provided along with the implant that can be used for the placement of the SUPPRELIN LA implant into the subcutaneous tissue of the inner aspect of the upper arm. The Insertion Tool is enclosed in a sterile bag and is provided separately from the implant in the Implantation Kit [see Recommended Procedure for Implant Insertion and Removal].
SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP).
Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment.
Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (LH) and follicle stimulating hormone (FSH) following stimulation with a GnRH analog, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia.
Recommended Dose
The recommended dose of SUPPRELIN LA is one implant every 12 months. Each implant contains 50 mg histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin acetate (65 mcg/day) for 12 months of hormonal therapy. SUPPRELIN LA should be removed after 12 months of therapy (the implant has been designed to allow for a few additional weeks of histrelin acetate release, in order to allow flexibility of medical appointments). At the time an implant is removed, another implant may be inserted to continue therapy. Discontinuation of SUPPRELIN LA should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).
Recommended Procedure For Implant Insertion And Removal
This procedure section is intended to provide guidance for the insertion and removal of SUPPRELIN LA. The actual procedure used, however, is at the discretion of the qualified healthcare provider performing the procedure.
Insertion of a new implant can proceed using the following Suggested Insertion Procedure. If a previous SUPPRELIN LA implant must first be removed, please see the Suggested Removal Procedure instructions below.
Suggested Insertion Procedure
The supplies necessary to insert the implant, including the Insertion Tool and local anesthetic, are provided in a separate Implantation Kit that is shipped along with the implant. Please note that the implant should be kept refrigerated (2-8°C) in its sealed vial, pouch, and carton, until needed for the procedure. Once removed from refrigeration, the vial containing the implant (still in its unopened pouch and carton) may remain at room temperature for up to 7 days, if necessary, before being used. If not used in that time, the packaged implant may again be properly refrigerated until the expiration date on the carton.
NOTE: The Implantation Kit is to be stored at room temperature and should not be refrigerated.
Insertion of the SUPPRELIN LA implant is a surgical procedure. Sterile gloves and aseptic technique must be used to minimize any chance of infection.
Setting up the Sterile Field
Using proper aseptic technique, the sterilized components of the Implantation Kit needed for the insertion procedure, including the Insertion Tool, are to be carefully dispensed from their packaging onto the Sterile Field drape (non-fenestrated) provided. NOTE THAT THE KIT BOX AND ALL PACKAGING ARE NOT STERILE and should be kept off of the Sterile Field drape. DO NOT PLACE THE VIAL OF LOCAL ANESTHETIC OR THE VIAL CONTAINING THE IMPLANT ONTO THE DRAPE as the exterior surface of these vials is not sterile.
The implant vial should not be opened until just before the time of insertion. Open the vial by removing the metal band and carefully pour the sterile contents (implant and sterile saline) onto the Sterile Field drape. The implant can then be handled with sterile gloves or with the sterile mosquito clamp provided. AVOID bending or pinching the implant.
Preparing the Patient and the Insertion Site
The patient should be on his/her back, ideally with the arm least used (e.g., left arm for a right-handed person) positioned, either bent or extended, so that the physician has ready access to the inner aspect of the upper arm. Propping the arm with pillows may help the patient more easily hold the position. The suggested optimum site for subcutaneous insertion is approximately half-way between the shoulder and the elbow, in line with the crease between the biceps and triceps muscles.
Swab the insertion area with topical antiseptic, then overlay with the fenestrated Sterile Field drape provided, so that the opening is over the insertion site (for clarity of illustration, the following images do not show the drape).
The method of anesthesia utilized (i.e., local, conscious sedation, general) is at the discretion of the healthcare provider.
If Local Anesthesia is Selected
A vial of sterile local anesthetic (note that the exterior of the vial is not sterile) has been provided along with a sterile hypodermic needle for injection. After determining the absence of known allergies to the anesthetic agent, inject anesthetic into the subcutaneous tissue, starting at the planned incision site, then infiltrating along the intended subcutaneous insertion path, up to the length of the implant (a little more than one inch). Local anesthesia may also be supplemented by the use of distraction techniques.
The following sections describe the suggested procedure for insertion of the implant using the Insertion Tool provided. The method of insertion used, however, is at the discretion of the healthcare provider performing the procedure.
Loading the Insertion Tool
The sterile Insertion Tool is comprised of a fixed handle attached to a retractable, bevel-tipped cannula, into the chamber of which the implant is to be placed for subcutaneous insertion. The cannula can be extended and retracted. The fully extended cannula contains a fixed piston upon which the implant, once inserted, rests. During the final step of the insertion procedure, the cannula will be retracted into the handle using the slide mechanism (green button), thereby exposing and leaving the implant to remain in the subcutaneous tissue.
When first grasping the sterile Insertion Tool, confirm that the cannula is fully extended. Verify this by inspecting the position of the green retraction button. The button should be locked in position all the way forward, towards the cannula, farthest from the handle.
The implant can be picked up using sterile gloves or with the sterile mosquito clamp provided. Avoid bending or pinching the implant. Note that the implant may come out of its vial slightly curved and/or partially flattened after refrigerated storage. To help make the implant more symmetrical prior to loading into the Tool, you can roll the implant a few times (while wearing a sterile glove) between the fingers and thumb.
Insert the implant into the cannula of the Insertion Tool manually or using the mosquito clamp. When inserting the implant into the cannula, DO NOT FORCE the implant. If resistance is felt, the implant should be removed and manually manipulated or rolled as needed, and re-inserted into the cannula.
When fully inserted, the implant rests inside the cannula so that just the tip of the implant is visible at the beveled end of the cannula.
Making the Incision
Using the sterile scalpel provided, make an incision transverse to the long axis of the arm, and of a size adequate to allow the bore of the cannula to be inserted into the subcutaneous tissue. Be sure that the incision is positioned so that there is sufficient length of upper arm available to fit the implant easily within the intended insertion space.
Inserting the Implant
It is suggested that insertion may be easier if a "pocket" for the implant is first created by blunt dissection through the incision, subcutaneously along the path of the anesthetic, using the cannula of the loaded Insertion Tool, or using a sterile hemostatic clamp or equivalent surgical tool.
Be sure to VISIBLY RAISE THE SKIN (known as tenting) at all times during the pocket-making and insertion procedures to ensure correct subcutaneous placement ("just under the skin") of the implant. Note that the cannula of the Insertion Tool, or whatever tool is being used to create the pocket, SHOULD NOT ENTER MUSCLE TISSUE. Deep insertion of the implant will not affect the performance of SUPPRELIN LA, but may cause difficulty in the later removal of the implant.
If using the cannula of the loaded Insertion Tool to create the pocket, carefully insert the tip of the cannula into the incision and advance through the subcutaneous tissue, while visibly raising the skin along the length of the cannula up to, but no farther than, the inscribed black line on the cannula. DO NOT DEPRESS THE GREEN RETRACTION BUTTON ON THE TOOL WHILE INSERTING OR ADVANCING THE TOOL INTO THE INCISION.
Pull the Tool back, almost to the beveled tip of the cannula, and advance the Tool forward again, so that the cannula reenters the pocket completely, but no farther than the inscribed black line. Be sure to keep the insertion path just immediately subcutaneous.
If another tool was used to create the pocket, now insert the loaded cannula of the Insertion Tool containing the implant through the incision, up to the inscribed black line.
Hold the Insertion Tool in place with the base against the patient's arm (if possible) as you carefully move your thumb to the green retraction button. Depress the button to release the locking mechanism, then slide the button back toward the handle until it stops, all the while holding the body of the Insertion Tool in place.
Retracting the button causes the cannula to withdraw from the incision, leaving the implant in the subcutaneous tissue. DO NOT FURTHER ADVANCE THE CANNULA ONCE THE RETRACTION PROCESS HAS STARTED. Likewise, do not withdraw the Insertion Tool until the button is fully retracted or the implant may be pulled partially out of the incision. Once the retraction is complete, the Tool can be fully withdrawn.
NOTE: It may be helpful during the process of retraction and withdrawal of the cannula to apply pressure to the skin over the implant, to help ensure that the implant remains in the subcutaneous pocket.
If there is a need to re-start the process at any time during the insertion procedure, withdraw the Insertion Tool, carefully extract the implant from the cannula and reset the retraction button on the Tool to its forward-most position. Examine the implant before reloading the implant into the Insertion Tool, and start again.
Placement of the implant should be confirmed by palpation. Note that the tip of a properly-placed implant may not be visible through the incision.
After implantation, briefly cover the site with a sterile gauze pad and apply pressure to ensure hemostasis.
Closing the Incision
To close the incision, you can use the absorbable sutures and/or the sterile adhesive surgical strips provided. To improve adhesion of the strips, you can apply benzoin tincture antiseptic (provided) to the skin, and let it dry, before applying the adhesive strips.
Once closed, cover the incision site with sterile gauze pads and secure the dressing with the bandage provided.
Please provide the patient's parent or guardian with a Patient Information Leaflet, which includes information about the implant and instructions on proper care of the insertion site.
Suggested Removal Procedure
SUPPRELIN LA should be removed after 12 months of therapy. Most of the supplies necessary to remove the implant, including the local anesthetic and the sterile mosquito clamp, are provided in the Implantation Kit that is shipped along with a new SUPPRELIN LA implant. Note that the Implantation Kit is to be stored at room temperature and must not be refrigerated. See the Suggested Insertion Procedure above for further instructions.
Removal of the SUPPRELIN LA implant is a surgical procedure. Sterile gloves and aseptic technique must be used to minimize any chance of infection.
Setting up the Sterile Field
Using proper aseptic technique, the sterilized components of the Implantation Kit needed for the implant removal procedure are to be carefully dispensed from their packaging out onto the Sterile Field drape (non-fenestrated) provided. NOTE THAT THE KIT BOX AND ALL PACKAGING ARE NOT STERILE and should be kept off of the Sterile Field drape. DO NOT PLACE THE VIAL OF LOCAL ANESTHETIC ONTO THE DRAPE as the exterior surface of the vial is not sterile.
Preparing the Patient and the Site
The patient should be on his/her back, with the arm containing the implant positioned, either bent or extended, so that the physician has ready access to the inner aspect of the upper arm. Propping the arm with pillows may help the patient more easily hold the position.
The implant to be removed should first be located by palpating the inner aspect of the upper arm, near the incision from the prior year.
Generally, the previous implant is readily palpated. In the event the implant is difficult to locate, ultrasound may be used. If ultrasound fails to locate the implant, other imaging techniques such as CT or MRI may be used to locate it (plain films are not recommended as the implant is not radiopaque).
Swab the area above and around the previous implant with topical antiseptic. Overlay the area with the fenestrated Sterile Field drape provided, so that the hole is over the previous insertion site (for clarity of illustration, the following images do not show the drape).
The method of anesthesia utilized (i.e., local, conscious sedation, general) is at the discretion of the healthcare provider.
If Local Anesthesia is Selected
A vial of sterile local anesthetic (note that the exterior of the vial is not sterile) has been provided along with a sterile hypodermic needle for injection. After determining the absence of known allergies to the anesthetic agent, inject anesthetic into the subcutaneous tissue at and around the site of the intended incision (the site of the previous implant). Local anesthesia may also be supplemented by the use of distraction techniques.
Making the Incision and Removing the Implant
Using the sterile scalpel provided, make an incision of a size adequate to allow the implant to be easily removed and, if a new implant will be inserted, large enough for the bore of the cannula of the Insertion Tool provided.
Generally, the tip of the implant will be visible through the incision, possibly covered by a pseudocapsule of tissue. In order to facilitate the removal of the implant, it may be necessary to palpate the head of the implant through the incision using your smallest finger, especially if the head of the implant is not readily visible. In addition, you may need to push down on the distal end of the implant and "massage it forward" towards the incision.
Carefully nick the pseudocapsule to reveal the polymer tip of the implant. It may be beneficial to insert the sterile mosquito clamp provided into the hole created in the pseudocapsule and expand by opening the clamp. Widening the opening of the pseudocapsule may ease the extraction of the implant.
Gently but securely grasp the implant with the sterile mosquito clamp and extract the implant.
Dispose of the implant in a proper manner, treating it like any other bio-waste.
Briefly cover the site with a sterile gauze pad and apply pressure to ensure hemostasis.
If inserting a new implant, see the Suggested Insertion Procedure instructions provided above. Note that you can insert the new implant into the same "pocket" as the removed implant, or make a new incision at a different site in the same arm or in the contralateral arm.
If a new implant is not to be inserted, proceed to close the incision.
Closing the Incision
To close the incision, you can use the absorbable sutures and/or the sterile adhesive surgical strips provided. To improve adhesion of the strips, you can apply benzoin tincture antiseptic (provided) to the skin, and let it dry, before applying the adhesive strips.
Once closed, cover the incision site with sterile gauze pads and secure the dressing with the bandage provided.
Dosage Forms And Strengths
SUPPRELIN LA is a sterile, nonbiodegradable, diffusion-controlled, hydrogel polymer reservoir drug delivery system designed to deliver histrelin acetate continuously for 12 months after subcutaneous implantation. The sterile implant contains 50 mg histrelin acetate and delivers approximately 65 mcg histrelin acetate per day over 12 months.
Storage And Handling
SUPPRELIN LA (NDC 67979-002-01) is supplied in a corrugated shipping carton that contains 2 inner cartons: a small one for the vial containing the SUPPRELIN LA implant, which is shipped with a cold pack inside a polystyrene cooler that must be refrigerated upon arrival, and a larger one comprising the Implantation Kit, which must not be refrigerated, for use during insertion or removal of SUPPRELIN LA.
The SUPPRELIN LA implant contains 50 mg of histrelin acetate. The SUPPRELIN LA implant carton contains a cold pack for refrigerated shipment and a small carton containing an amber plastic pouch. Inside the pouch is a glass vial with a Teflon-coated stopper and an aluminum seal, containing the implant in 2 mL of sterile 1.8% sodium chloride solution. (Note: The 3.5 mL vial is not completely filled with saline).
Upon receipt, refrigerate the small carton containing the amber plastic pouch and glass vial (with the implant inside) until the day of insertion. The implant vial should not be opened until just before the time of insertion.
SUPPRELIN LA is stable when stored refrigerated, in its sealed vial, pouch, and carton, at 2-8°C (36-46°F) until the expiration date provided. Excursion permitted to 25°C (77°F) for 7 days. Do not freeze. Protect from light.
Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355.Revised Apr 2022.
The following serious adverse reactions are described here and elsewhere in the label:
- Initial Agonist Action [see WARNINGS AND PRECAUTIONS]
- Implant Breakage [see WARNINGS AND PRECAUTIONS]
- Psychiatric Events [see WARNINGS AND PRECAUTIONS]
- Convulsions [see WARNINGS AND PRECAUTIONS]
- Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [see WARNINGS AND PRECAUTIONS]
Overall Adverse Reaction Profile
The most common adverse reactions with SUPPRELIN LA involved the implant site. Local reactions after implant insertion include bruising, pain, soreness, erythema and swelling.
During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms may be observed [see WARNINGS AND PRECAUTIONS].
Adverse Reactions In Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of SUPPRELIN LA in children with CPP was evaluated in two single-arm clinical trials conducted in a total of 47 patients (44 females and 3 males) over a period of time ranging from 9 to 18 months. The most commonly reported adverse reaction was implant site reaction, which was reported by 24 of 47 (51.1%) patients. Implant site reaction includes discomfort, bruising, soreness, pain, tingling, itching, implant area protrusion and swelling. Two subjects experienced a serious adverse reaction: 1 subject who coincidentally had Stargardt's Disease experienced amblyopia and 1 subject had a benign pituitary tumor (pituitary adenoma). One subject discontinued the study due to an adverse reaction of infection at the implant site. There were no clinically meaningful findings in standard clinical hematology and chemistry tests and/or in vital signs. The incidence of implantation adverse events reported by more than 2 patients are summarized in Table 1.
Table 1: Incidence of implantation adverse reactions reported by ≥ 2 patients treated with SUPPRELIN LA in both clinical trials
|Adverse Reactions
|Implant site reaction
|24 (51.1)
|Keloid scar
|3 (6.4)
|3 (6.4)
|Suture related complication
|3 (6.4)
|Application site pain
|2 (4.3)
|Post procedural pain
|2 (4.3)
The following adverse reactions were reported as possibly related or related in 1 patient each: wound infection, breast tenderness, dysmenorrhea, epistaxis, erythema, feeling cold, gynecomastia, headache, menorrhagia, migraine, mood swings, pituitary tumor benign, pruritus, weight increased, disease progression and influenza-like illness. The adverse reaction metrorrhagia was reported as possibly related or related in 2 patients.
Post-Marketing Experience
The following adverse reactions have been identified during post approval use of SUPPRELIN LA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General Disorders and Administration Site Conditions: implant breakage
Psychiatric Disorders: Emotional lability, such as crying, irritability, impatience, anger, and aggression. Depression, including rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.
Nervous System Disorders: seizures. Pseudotumor cerebri (idiopathic intracranial hypertension) have been observed with GnRH agonists.
No formal drug-drug, drug-food, or drug-herb interaction studies were performed with SUPPRELIN LA.
Drug-Laboratory Interactions
Therapy with SUPPRELIN LA results in suppression of the pituitary-gonadal system. Results of diagnostic tests of pituitary gonadotropic and gonadal functions conducted during and after SUPPRELIN LA therapy may be affected. SUPPRELIN LA decreased mean serum insulin-like growth factor-1 (IGF-1) levels by approximately 11% in one study (Study 1). SUPPRELIN LA increased the serum concentration of dehydroepiandrosterone (DHEA) in 8 of 36 patients in another study (Study 2).
Included as part of the "PRECAUTIONS" Section
Initial Agonistic Action
SUPPRELIN LA, like other GnRH agonists, initially causes a transient increase in serum concentrations of estradiol in females and testosterone in both sexes during the first week of treatment. Patients may experience worsening of symptoms or onset of new symptoms during this period. However, within 4 weeks of histrelin therapy, suppression of gonadal steroids occurs and manifestations of puberty decrease.
Implant Breakage
Implant insertion is a surgical procedure and it is important that the insertion instructions are followed to avoid potential complications. The insertion and removal of the implant should be done aseptically. Proper surgical technique is critical in minimizing adverse events related to the insertion and the removal of the histrelin implant. On occasion, localizing and/or removal of implant products have been difficult and imaging techniques were used, including ultrasound, CT, or MRI (note: the histrelin implant is not radiopaque). In some cases the implant broke during removal and multiple pieces were recovered. Confirm that the entire implant has been removed. If the implant was not retrieved completely, the remaining pieces should be removed following the instructions in the Suggested Removal Procedure section [see DOSAGE AND ADMINISTRATION]. Rare events of spontaneous extrusion of the implant have been observed in clinical trials. During SUPPRELIN LA treatment, patients should be evaluated for evidence of clinical and biochemical suppression of CPP manifestations (see Section 5.6, Monitoring And Laboratory Tests). Detailed instructions on the insertion and removal procedures of the implant are provided above [see DOSAGE AND ADMINISTRATION].
Psychiatric Events
Psychiatric events have been reported in patients taking GnRH agonists, including SUPPRELIN LA. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with SUPPRELIN LA [see ADVERSE REACTIONS].
Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including SUPPRELIN LA. Reports with GnRH agonists have included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.
Monitoring And Laboratory Tests
LH, FSH and estradiol or testosterone should be monitored at 1 month post implantation then every 6 months thereafter. Additionally, height (for calculation of height velocity) and bone age should be assessed every 6-12 months.
Patient Counseling Information
Advise the patient to read the FDA-Approved patient labeling (PATIENT INFORMATION).
Initial Agonistic Action
Patients should be advised that a transient worsening of symptoms of puberty or onset of new symptoms may occur initially. However, within 4 weeks of histrelin therapy, complete suppression of gonadal steroids occurs and manifestations of puberty decrease [see WARNINGS AND PRECAUTIONS].
Post-Insertion Care
Patients should be instructed to refrain from getting the inserted arm wet for 24 hours and from strenuous exertion of the inserted arm for 7 days after implant insertion to allow the incision to fully close. The adhesive elastic bandage can be removed at that time. The patient should not remove the surgical strips; rather, the strips should be allowed to fall off on their own after several days.
Psychiatric Adverse Events
Inform caregivers that symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression, have been observed in patients receiving GnRH agonists, including SUPPRELIN LA. Alert caregivers to the possibility of development or worsening of psychiatric symptoms, including depression, during treatment with SUPPRELIN LA [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS].
Inform caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including SUPPRELIN LA. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at risk [see WARNINGS AND PRECAUTIONS].
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Inform patients and caregivers that reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists. Advise patients and caregivers to monitor for headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea. Advise patients and caregivers to contact their healthcare provider if the patient develops any of these symptoms. [see WARNINGS AND PRECAUTIONS].
Common Adverse Reactions
Patients should be advised to report to their physician any severe pain, redness, or swelling in and around the implant site. Infrequently, SUPPRELIN LA may be expelled from the body through the original incision site, rarely without the patient noticing. The patient should be instructed to monitor the incision site until it is healed. The patient should also return for routine checks of their condition and to ensure that SUPPRELIN LA is present and functioning in his/her body [see ADVERSE REACTIONS].
For more information, call 1-800-462-3636 or visit www.supprelinla.com.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity studies were conducted in rats for 2 years at doses of 5, 25 or 150 mcg/kg/day (up to 11 times human exposures using body surface area comparisons, based on a 65 mcg/day dose in humans) and in mice for 18 months at doses of 20, 200, or 2000 mcg/kg/day (at less than therapeutic exposure to 70 times human exposure using body surface area comparisons, based on a 65 mcg/day dose in humans). As seen with other GnRH agonists, histrelin injection administration was associated with an increase in tumors of hormonally responsive tissues. There was a significant increase in pituitary adenomas in rats at mid and high doses (2-11 times human exposure based on body surface area comparisons with a 65 mcg/day human dose). There was an increase in pancreatic islet-cell adenomas in treated female rats and a non-dose-related increase in testicular Leydig-cell tumors (highest incidence in the low-dose group). In mice, there was significant increase in mammary-gland adenocarcinomas in all treated females. In addition, there were increases in stomach papillomas in male rats given high doses, and an increase in histiocytic sarcomas in female mice at the highest dose.
Mutagenicity studies have not been performed with histrelin acetate. Saline extracts of implants with and without histrelin acetate were negative in a battery of genotoxicity studies. Fertility studies have been conducted in rats and monkeys given subcutaneous daily doses of histrelin acetate up to 180 mcg/kg/day (up to 13 and 30 times human exposure, respectively using body surface area comparisons, based on a 65 mcg/day human dose) for 6 months and full reversibility of fertility suppression was demonstrated. The development and reproductive performance of offspring from parents treated with histrelin acetate has not been investigated.
Use In Specific Populations
Risk Summary
SUPPRELIN LA is contraindicated during pregnancy [see CONTRAINDICATIONS] since expected hormonal changes that occur with SUPPRELIN LA treatment increase the risk for pregnancy loss. The limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. Consistent with mechanism of action for SUPPRELIN LA [see CLINICAL PHARMACOLOGY], animal reproduction studies showed an increase in fetal loss at clinically relevant exposures.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Animal Data
Histrelin acetate administered to pregnant rats during the period of organogenesis increased fetal mortality and postimplantation loss at doses of 1, 3, 5 or 15 mcg/kg/day, approximating clinical exposure based on body surface area. These dosages also reduced maternal body weight gain, stimulated ovarian follicular development, increased placental weight and caused abnormal morphology and an increase in fetal size. Histrelin acetate administered to pregnant rabbits during the period of organogenesis increased fetal mortality and abortion/early termination at the two highest doses and caused total litter loss at all doses of 20, 50 or 80 mcg/kg/day (approximately 3- to 12-times clinical exposures based on body surface area).
Risk Summary
There are no data on the presence of SUPPRELIN LA in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Absorption and systemic activity are not expected from potential exposure to the peptide, histrelin, in the breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SUPPRELIN LA and any potential adverse effects on the breastfed child from SUPPRELIN LA or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established. The use of SUPPRELIN LA in children under 2 years is not recommended.
There have been no reports of overdose in SUPPRELIN LA clinical trials. High doses of histrelin acetate injection in animal studies were generally associated only with effects attributed to the expected pharmacology. The method of drug delivery makes accidental or intentional overdosage unlikely.
SUPPRELIN LA is contraindicated in:
- Patients who are hypersensitive to gonadotropin releasing hormone (GnRH) or GnRH agonist analogs
- Pregnancy [see Use In Specific Populations].
Mechanism Of Action
SUPPRELIN LA is a GnRH agonist and an inhibitor of gonadotropin secretion when given continuously. It delivers approximately 65 mcg histrelin acetate per day. Both animal and human studies indicate that following an initial stimulatory phase, chronic, subcutaneous administration of histrelin acetate desensitizes responsiveness of the pituitary gonadotropin which, in turn causes a reduction in ovarian and testicular steroidogenesis.
In humans, administration of histrelin acetate results in an initial increase in circulating levels of LH and FSH, leading to a transient increase in concentration of gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females).
However, continuous administration of histrelin acetate causes a reversible down-regulation of the GnRH receptors in the pituitary gland and desensitization of the pituitary gonadotropes. These inhibitory effects result in decreased levels of LH and FSH.
Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Consequently, secondary sexual development ceases to progress in most patients. Additionally, linear growth velocity is slowed which improves the chance of attaining predicted adult height.
Pharmacokinetics of histrelin after implantation of SUPPRELIN LA was evaluated in a total of 47 children with CPP (11 subjects in Study 1 and 36 subjects in Study 2). Patients were examined at 4 weeks after implant insertion and a few times throughout the treatment period. Median serum histrelin concentrations remained above the limit of quantification for the treatment period. Histrelin acetate levels were sustained throughout the study period for most subjects (Figure 3). The median of maximum serum histrelin concentrations over the study period was 0.43 ng/mL, which is expected to maintain gonadotropins at prepubertal levels. There was no apparent pharmacokinetic difference between naïve subjects to a LHRH agonist treatment and subjects who had previous treatment with a LHRH agonist (Figure 3).
Figure 3. Mean and Standard Deviation of Serum Histrelin Concentrations (ng/mL) Results at Each Visit
Clinical Studies
The efficacy of SUPPRELIN LA in children with CPP has been evaluated in two single-arm, open label studies. Study 1 was conducted in 11 pretreated female patients, 3.7 to 11.0 years of age. Study 2 was conducted in 36 patients (33 females and 3 males), 4.5 to 11.6 years of age. Sixteen pretreated and 20 treatment-naïve patients were enrolled in Study 2. Baseline patient characteristics were typical of patients with CPP. Efficacy assessments were similar in both studies and included endpoints that measured the suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment. Other assessments were clinical (evidence of stabilization or regression of signs of puberty) or gonadal steroid-dependent (bone age, linear growth). In Study 2, the primary measure of efficacy was LH suppression.
In Study 2, suppression of LH was induced in all treatment naïve subjects and maintained in all pretreated subjects at Month 1 after implantation and continued through Month 12 (suppression was defined as a peak LH < 4 mIU/mL following stimulation with the GnRH analog leuprolide acetate).
Secondary efficacy hormone assessments (FSH, estradiol and testosterone) and additional efficacy assessments (bone age advancement, linear growth, clinical progression of puberty) indicated stabilization of disease. Estradiol suppression was present in all 33 girls (100%) through Month 9 and 97% at Month 12. Testosterone suppression was maintained in the three pre-treated males participating in Study 2. The SUPPRELIN LA effect on efficacy endpoints in the Study 1 was consistent with that observed in Study 2.
Suh-Preh-Lin El-Ay]
(histrelin acetate) subcutaneous implant
What is the most important information I should know about SUPPRELIN LA?
Call your child's doctor right away if your child has any new or worsening mental symptoms or problems while taking SUPPRELIN LA.
Seizures have also happened in people who have not had any of these problems.
Call your child's doctor right away if your child has a seizure while taking SUPPRELIN LA.
Call your child's doctor right away if your child has any of the following symptoms during treatment with SUPPRELIN LA:
- In the first week of treatment, SUPPRELIN LA can cause an increase in some hormones. During this time you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. Within 4 weeks of treatment, you should see signs in your child that puberty is stopping.
- Some people who had SUPPRELIN LA placed in their arm have had the implant come through the skin (extrusion). Call your child's doctor right away if the SUPPRELIN LA implant comes through the skin.
- Some people taking GnRH agonists like SUPPRELIN LA have had new or worsening mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:
- crying
- irritability
- restlessness (impatience)
- anger
- acting aggressive
- Some people taking GnRH agonists like SUPPRELIN LA have had seizures. The risk of seizures may be higher in people who:
are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs)
- have a history of seizures
- have a history of epilepsy
- have a history of brain or brain vessel (cerebrovascular) problems or tumors
- Increased pressure in the fluid around the brain can happen in children taking GnRH agonist medicines including SUPPRELIN LA.
- headache
- ringing in the ears
- eye problems, including blurred vision, double vision, and decreased eyesight
- dizziness
- nausea
- eye pain
What is SUPPRELIN LA?
- SUPPRELIN LA is an implanted gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP).
- It is not known if SUPPRELIN LA is safe and effective in children under 2 years of age.
SUPPRELIN LA should not be taken if your child is:
- allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any ingredients in the SUPPRELIN LA implant. See the end of this Medication Guide for a complete list of ingredients in SUPPRELIN LA.
- pregnant or becomes pregnant. SUPPRELIN LA can cause birth defects or loss of the baby. If your child becomes pregnant call your doctor.
Before your child receives SUPPRELIN LA, tell the doctor about all of your child's medical conditions, including if they:
- have a history of mental (psychiatric) problems.
- have a history of seizures.
- have a history of epilepsy.
- have a history of brain or brain vessel (cerebrovascular) problems or tumors.
- are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs).
Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will your child receive SUPPRELIN LA?
- Your child's doctor should do tests to make sure your child has CPP before treating with SUPPRELIN LA.
- SUPPRELIN LA lasts for 12 months. One implant will give the medicine for 12 months. After 12 months, the SUPPRELIN LA implant must be removed. The doctor may place a new SUPPRELIN LA implant at this time to continue treatment.
- SUPPRELIN LA is placed under the skin of the inside of the upper arm. The doctor will numb the arm of your child, make a small cut, and then place the SUPPRELIN LA implant under the skin. The cut may be closed with stitches or surgical strips and covered with a pressure bandage.
- Your child should keep the arm clean and dry and should not swim or bathe for 24 hours after receiving the SUPPRELIN LA implant. The bandage can be removed after 24 hours. Do not remove any surgical strips. Surgical strips will fall off on their own in a few days.
- Your child should avoid heavy play or exercise that uses the arm where the implant was placed for 7 days. After the cut has healed, your child can go back to his or her normal activities. The doctor will give you complete instructions.
- Keep all scheduled visits to the doctor. The doctor will do regular exams and blood tests to check for signs of puberty.
- Sometimes the doctor will have to do special tests, such as an ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) if the SUPPRELIN LA implant is hard to find under your child's skin.
What are the possible side effects of SUPPRELIN LA?
SUPPRELIN LA may cause serious side effects. See "What is the most important information I should know about SUPPRELIN LA?"
The most common side effect of SUPPRELIN LA includes skin reactions at the place where the implant is inserted. These reactions may include pain, redness, bruising, soreness, and swelling in and around the implant site. Call your child's doctor if your child has bleeding, redness, or severe pain where the implant was inserted.
These are not all the possible side effects of SUPPRELIN LA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What are the ingredients in SUPPRELIN LA?
Active ingredient: histrelin acetate
Inactive ingredients: stearic acid NF, hydrogel polymer reservoir composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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text:
Teaching at a top-ranked high school in SF
He has been a teacher at Lo High School - a top-ranked high school in San Francisco - for over 20 years.
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Teaching at a top-ranked high school in SF
He has been a teacher at Lo High School - a top-ranked high school in San Francisco - for over 20 years.
You've got a week or two before the Advanced Placement exam, you've done your practice, you've done your homework, you've taken multiple choice exams, now let's get ready for the free response section. We'd like to give you a few tools today, that you can use when you take that exam. When you open up the booklet, that's a process that you can rely on. So let's take a look.
You did your multiple choice exam, you took your break. You know when you open that booklet, you're going to see four questions. You know that you're going to have a hundred minutes to take that test, so far so good. What I like you to do, is to scan the entire document. Read all four questions, and try to asses which one of the questions is going to be the easiest, which one might be just a little bit harder. I've got the information, but maybe I need to spend a little more time with it. Then there'll be that compound question, a little bit more complex, part A, part B. I'm going to leave more time for that. And then the most difficult question, or in the worst case, the 'Oh my God' question. You know that you don't have to do these questions in the order that they're presented. So I like the easiest ones first. Let's get some momentum and makes sure that we have time for the most difficult question.
You're ready to get started? Let's take a look at the first question. This is the question that I think is the easiest question. I'm going to start with this one. First thing I'm going to do, scan the question. "American Federal elections are often difficult for challengers to win. Identify and explain four factors that give incumbents the advantage in Congressional elections. Then, explain one way in which the incumbent advantage can be overcome." So I've scanned the question, now I'm going to identify the task that they're asking me to do.
First thing I need to do, is identify and describe four factors here that give incumbents the advantage. I know these things. I remember them from the re-election section in chapter eight. So identify, I've just got to name than. So I'll do that, no problem there. But to describe it, I need to give the AP or the College Board just a little bit more. So, first one, I'm going to talk about gerrymandering. And that I know that gerrymandering is the re-districting for the advantage of one political party or another. I'm going to mention that here.
Second thing I'm going to do, I'm going to talk about the money involved. An incumbent always has money advantage, almost always has money advantage. Often two or three times that of which a challenger would have. More money for media, more money for direct mail, it's a killer. So I'm going to mention the money, media and direct mail.
The third thing, we've got the pork barrel, or ear marks. I can hear John McCain somewhere in the background talking about earmarks. If I'm a congressman, if I have access to public works money, I'm going to bring some of that money home to my district. I'm going to make sure that the people in my district got heard and they're going to like me. They're not going to be able to pick up on a challenger.
And the fourth thing is, they're going to know who I am. Because, I'm going to make sure that I get back, we're going to have plenty of time to hold meetings. I'm going to use my franking privilege, it's something that I could also use there. What I have I done here? I've identified four things that give incumbents the advantage, and now I've began to describe them. Here is my brainstorm, I'm ready to move on to the second part of the question.
Explain one way in which the incumbent advantage can be overcome. We already know what the advantages are, let's just see if we can turn it around. I'm going to start my brainstorming process. I know that sometimes a person who is independently wealthy, can have access to direct mailing. They can be the ones that can go negative. They might actually have a name that people recognize. So these are the advantages of the incumbent, but they can also be the advantages of the challenger. Imagine if somebody with money, can put out a direct mail and they can tie an incumbent with a failed policies of an incumbent president for example. These are the kinds of things we're looking for.
You're ready for something more difficulty? Let's briefly review the steps. First thing you did, you scanned the question. Second thing you did, you identified what it was that they were asking you to do. Did we do it? We identified, we described and then finally, we did the brainstorm for part one, we did the brainstorm for part two. Let's try something just a little bit harder now.
Let's try a question that's a compound question. But I want you to keep in mind, the steps that you're going to go through. Go ahead and go to your bonus materials, download the question, and then, we'll come back here in five minutes and take a look at it. I'll wait for you.
We're back. That one was a little bit tougher. Let's see how you did. First thing you do, let's scan the question. "Different interest groups will choose different techniques to achieve their objectives based ion their resources, characteristics and goals. Describe two of the following techniques and explain why an interest group would chose that technique." Before I get bogged down in this particular part of it, I'm going to check part B of that to make sure that if my choice is linked to part B, I'd better make the right choice.
"Select one of the following groups and identify the primary technique it uses from the list above. Explain why the group you selected would employ that technique more than any one from the above list." So now I know they're independent. I get to make my choice in part A.
What's our process, we've scanned the question, now let's identify what they want us to do. Describe two of the following techniques. So we know that it's going to be two, the techniques that we want to them to explain; why the interest group would chose the technique. Maybe I'm not sure what Amicus Curiae is, and I know a little bit about financial campaign contributions. I do like litigation, I like grassroots lobbying, I like the initiative.
I'm going to start with the one that I thing is the strongest. The grassroots lobby. I'm going to make sure that they know that I know the difference between lobbying from an interest group or a pack and grassroots lobbying, where a large number of citizens are going to try to influence a piece of legislation. I'm going to start with that. Two of the following techniques and explain why they would choose that technique.
First of all, in grassroots lobbying, maybe I'm trying to influence a piece of legislation. It's possible in a very large group, in a very large membership, that we can bring to bear 10, 20, 30 thousand emails in a single day. The national rifles association for example, has been known to boast that they could get a 100 thousand emails to a particular congress man on a particular day. Think about the pressure that that would exert, in order to exert their influence. We've identified our group, we've told them why we we've done it.
Second one, litigation. I like this one because I know that litigation is a law suit and these are completely different circumstances. Somebody who file a suit, is going to be probably not have access to any of the other ways to influence here. They're going to have a smaller membership; they're not going to have as much money. They might not be in the popular majority, and this is the term, how they're going to make the social change. I like litigation, so litigation means filing suit. I'm going to do that. It's the most effective way to get my interest met, to create social change.
Now let's take a look at the second part of the question. "Select one of the following groups and identify the primary techniques it uses from the list above." We're going to take one of the following groups and look at the primary technique from the list above. "Explain why the group you selected would employ that technique more than any other from the list."
I'm going to look at these groups right here and I know something about each one of these groups. But, the one I really like is, the National Association for The advancement of Colored People, (N.A.A.C.P). I know some court cases, I know a little bit of the history, and I know that I picked litigation at the top and maybe I can tie those two things together. What am I going to chose here? I need to identify what they're asking me to do. So I've selected my group, and I'm going to identify the primary technique that it uses from above. The N.A.A.C.P they're going to litigate. They have a relatively small membership. N.R.A. is going to have thirty times more members and that much more access to money. So how is the N.A.A.C.P. going to get their needs met? Through the courts, and we know that historically. We've chosen that, that's the best way to go.
Ballad Initiative, they don't necessarily represent a majority, so it's not going to be the ballad initiative. Grassroots lobbying, I don't think so. Membership basically very small. Campaign contributions, same as the above, not going to be able to do that if we have a very limited membership. And a friend of the court, Amicus Curiae, not going to be nearly as effective as litigation. What do we know about litigation? How about Brown versus Board of Education, 1954? It changed an entire way of thinking, and ended de jure segregation in the United States as we know it. So I'm going to include Brown versus Board of Education in my answer here.
Now I think I've answered the question, so let's review. What do we do here? We read the problem, we scanned the entire problem. We realized that part A and part B weren't linked. I hope you did the same thing. Secondly, we identified what they asked us to do. You just did the same thing as well. I made my choice of litigation, you may have chosen something else. But I hope that you were able to make sure that you could eliminate the other choices there, do exactly what they asked us to do and provide a salient example as well.
Now we've done these two. Here's what I'd like you to do. I'd like you to go to the College Board Website, and I'd like you to open up one of the practice tests. The free response test, somewhere between 2002 and 2008. And I'd like you to repeat the process that we started from the very beginning. So open it up, scan the four questions, asses the relative difficulty. Find the one that's the easiest, the second easiest, then all the way to the most difficult. And then I'd like you to start that process; scan the question, identify what they're asking you to do and then finally, do your brainstorm. Try one, try two. Once you get this process in your head, you're going to feel like there's no problem when you open up that test on the AP exam date.

subset: commoncrawl


text:
BOSTON – A fire driven by strong winds raced through a brownstone on Wednesday, trapping and killing two firefighters in the basement, where their colleagues couldn't rescue them.
Thirteen other firefighters were injured in the blaze, and several police officers also were taken to hospitals. Some residents had to be rescued from the upper floors of the four-story apartment building, but none was hurt, city officials said.
"Today's a sad day for the city of Boston," Mayor Marty Walsh said. "We lost two heroes here today."
The firefighters were identified as Lt. Edward J. Walsh, a 43-year-old father of three who had almost a decade of experience, and firefighter Michael R. Kennedy, a 33-year-old Marine Corps combat veteran who had been a firefighter for more than six years.
Deputy Fire Chief Joseph Finn said the fire appeared to have started in the basement but moved quickly through the building. The cause wasn't known, but he said all indications are that it was accidental and that it was the wind that caused the fire to spread through the building so quickly. Firewalls stopped the fire from consuming adjacent buildings.
"In 30 years I've never seen a fire travel that fast, escalate that quickly and create such havoc in such a short period of time," Finn said.
He said Walsh and Kennedy had gone down inside stairs into the basement, and he assumed that a front window broke out and blew the fire back at them. They called a mayday within two or three minutes of entering the building. Kennedy was found about 30 minutes later and was pulled from the building but was pronounced dead at a hospital. Walsh's body was recovered later.
Some of the other firefighters were injured when they were blown down stairs by a backdraft explosion caused by the wind, Finn said.
Major thoroughfare Storrow Drive was shut down for a time, and people were asked to stay out of the area until Thursday morning. The mayor's office designated the nearby Boston Public Library as a center for people displaced or otherwise affected by the fire to get help.
Despite 30 mph winds that gusted to 45 mph and cold temperatures, people gathered to watch firefighters work from outside the building, which was still burning Wednesday night.
"The smoke was unbelievable," said Kayla Dasilva, who lives a few blocks away and went with her roommate to see what was happening.
Anna Kosmidou, who lives in the apartment building next to the one that caught fire, said she and other residents were told they could not stay there Wednesday night.
"I'm very, very afraid. I'm still in shock," she said. "They called me at work, and then I ran over here."
The last Boston firefighter killed on duty died in 2009, when the fire truck in which he was riding struck a building after its brakes failed. Two firefighters died in 2007 battling a restaurant fire in the West Roxbury neighborhood.
At Engine 33/Ladder 15, Kennedy and Walsh's station, not far from the fire and in the shadow of the Prudential Center, people stopped by to pay their respects.
Ralph Watson, a middle school principal in Cambridge, left a bouquet of roses outside the station.
"We live just down from where the fire was. It's very sad," he said. "We were standing when they took, I think, one of them by in a stretcher."
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text:
The truth hurts – how far are politicans prepared to go to cover it up?
Back in May 2012 I watched a high-ranking officer from the City of London Police remove a final sticker from a lamppost. He then stood back to survey his good work outside the Grange Hotel near St Paul's Cathedral. There was now no sign at all of the day-long siege of the hotel by 400 non-violent climate activists trying to disrupt the UK Energy Summit.
At one point there had been an attempt by protesters to push through into the hotel and two activists were arrested. The police drew batons and beat back those caught in the front line. The activists were kettled for a few hours while police tried to force them to give their details. I watched as some young people were detained for having chalked messages on the pavement.
There was little coverage of this action but, predictably, criticism along the lines of 'Rent-a-mob trouble-makers with ill-thought-out arguments!' 'Give them a cold shower and take away their benefits!'Or 'How dare these losers take it upon themselves to know what's best for us?'
The action was directed against the Big Six energy companies who were meeting in the hotel. The same Big Six are now lambasted by both right-and left-wing figures as well as the press, for jacking up fuel prices while enjoying astronomic profits. There are suspicions of price fixing.
Back in 2012 the Climate Justice Collective had stated that the UK Energy Summit was a 'classic one-per-cent stitch up [of] corporate élites, including the government, conspiring to keep the status quo of high energy prices, soaring profits, growing climate instability and disaster capitalism. This conference is the wrong people, asking the wrong questions and proposing the wrong solutions.'
In Britain we are taught to dismiss or ridicule protest and to accept feeble excuses when we see protest violently suppressed. The last thing we are encouraged to do is to see civil disobedience as an indication of issues that must be addressed.
Activists are frequently accused of not having 'thought-through' arguments. But if you decide to put your body in front of your convictions, risking your liberty and safety, chances are you have thought things through pretty carefully.
Those participating have had to balance the personal risk with the injustice they are trying to prevent. In the case of Edward Snowden and the Greenpeace 30, for example, the risk is steep indeed are the injustices they are challenging are of epic, history-changing proportions.
When people who have made that choice turn out to have been right, the mainstream media and the government remain silent or may even steal the rhetoric. Occupy were correct when they said that the criminal bankers and their regulators should be paying for the crisis the one per cent caused and that the government should 'bang up the bankers'.
UK Uncut are correct about the importance of shutting down sophisticated tax loopholes to address economic crisis instead of hammering people with austerity. But it's only recently that the government have started addressing this.
Just like that schoolyard taunt 'It's the truth that hurts' it seems that the violence meted out on activists is relative to the level of discomfort that their truth telling causes. Climate Camp protesting against fossil fuel addictions faced $8.8 million worth of brutal and excessive policing at Kingsnorth in 2008.
Climate activists at Copenhangen for the Climate Conference were arrested in their hundreds, made to sit in the snow for five hours and then put into specially made cages. I watched as people were beaten and gassed, including a 74-year-old woman. But now, following the latest IPCC report, it's quite possible that Copenhagen was our last chance to address the oncoming ravages of climate change.
Which is worse? Governments that pursue policies that wreck the lives and aspirations of the poorest or citizens who watch this happening and do nothing?
We will not get radical change by commenting on websites, 'liking' something on Facebook or, dare I say it, by voting for a mainstream political party funded by a corporate and political élite. Neither will mainstream media support any genuinely radical change, for they are owned by a similar élite.
Brutally put, it's down to us to be human. I don't think that protesters or activists are behaving in a peculiar or unusual way, they are simply acting as thinking human beings. It is those who do nothing who are not.
Join Fuel Poverty Action, UK Uncut, the Greater London Pensioners' Association and Disabled People Against Cuts for a creative protest against fuel poverty deaths on Tuesday November 26 at 11.30am to 'Bring Down the Big Six'.
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text:
Colombia's military chief says the country's second-largest rebel band has kidnapped five gold mining workers in a northern province. They include a Canadian, two Peruvians and two Colombians.
Gen. Alejandro Navas tells The Associated Press that the five were seized Friday morning by two dozen rebels of the leftist National Liberation Army in the Bolivar state municipality of Norosi.
The rebel band known as the ELN has an estimated 1,500 figthers is far smaller than the Revolutionary Armed Forces of Colombia, which is currently engaged in peace talks with the government in Cuba.
The ELN has been seeking to join those talks but without success.
Unlike the larger group, the ELN has not renounced ransom kidnappings.


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Former creative consultant on Kanye West and Jay Z's Watch the Throne tour, Hunter Lee Soik, has started a Kickstarter campaign to fund an app which allows you to remember your dreams.
Named Shadow, the app works in a three-step process which allows you to wake up, record your dream, and then compare data with other users around the world. The goal is to tap in to our subconscious and understand the bigger picture through our dreams. The campaign is live until early November, in the hope of raising USD $50,000. A staggered launch is expected in the first third of next year, but until then here's a closer look. Show your support here.


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- Home
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- Housing and Community Services
- Affordable Housing
- Creating Affordable Housing - Town-Owned Land
Creating Affordable Housing - Town-Owned Land
Frequently Asked Questions
What action did the Town Council take on February 8, 2022, to advance affordable housing goals for Carrboro?
The Town Council approved a multi-step, sequential process to create affordable housing on selected town-owned parcels.
The first step in this process is to conduct a comprehensive site analysis of the identified parcels to determine what is (and isn't) possible on the property. This information will inform community engagement discussions and workshops, which will be scheduled during the second step in the process.
The Town Council has not approved a development plan on either the Crest Street or the Pathway Drive parcels.
You can review the Town Council Agenda item here.
How were properties selected for possible affordable housing locations?
A preliminary review of Town-owned properties was conducted in 2015 by staff and members of the Affordable Housing Task Force. Parcels were excluded if they were designated for another use, or if they met any of the following criteria:
- Within a conservation easement
- Inside a Long-Term Interest Areas for future utility development
- No water or sewer nearby
- Within 100-year floodplain
- Within dedicated right-of-way
- Parcel completely developed
- Inside Rural Buffer zoning
You can view the related Town Council agenda item here.
A map of Town-owned properties can be found here.
How many units will be built?
The site analysis must be conducted first to determine what is (and isn't) possible on the parcels, including the number of units. Any numbers that have been noted to date are theoretical and based on current zoning. The actual design/plans, and number of units, will be developed/determined in partnership with the community.
What's included in a preliminary site analysis?
A preliminary site analysis is an evaluation of the site's physical characteristics and a review of local, state, and federal regulatory requirements, both of which will identify issues that could affect development. For example, this analysis will test soil samples to provide information on soil erosion and soil-bearing strengths; define buildable area based on wetlands/setback requirements; and evaluate the topography.
More details about what's involved in a preliminary site assessment can be found here.
Re-Advertised - A Request for Qualifications (RFQ) notice for a site analysis has been published on the Town's website, on the Historically Underutilized Businesses site, in the Triangle Tribune, and in the Durham Herald Sun. The RFQ will be posted August 28, 2022 and can be found here. Submissions are due to the Town on September 23, 2022.
How can I stay involved?
The first step in the process is to conduct a site analysis to determine what is (and isn't) possible on the properties. Once the analysis is complete, the next step is to reach out to the neighborhood and Carrboro community to schedule community engagement opportunities.
Working with a design consultant, the community will be very involved in creating the goals for and design of future development based on information from the site analysis, the comprehensive plan, ongoing community engagement, property factors such as location, unit potential, and other Town priorities such as racial equity and climate action. There will be multiple opportunities for the public to engage in this process and affect the final design of the development. Additionally, a public hearing(s) will be held before the Town Council considers final approval.
We encourage residents to sign up to receive news and information that is sent directly to your email inbox. Visit www.carrboronc.gov/SIGNUP for Carrboro This Week (a weekly digest) and Carrboro Town News (more frequent updates). Included in the email newsletters are Town Council meeting agendas. The Town also publishes these same updates on Nextdoor, Facebook, Twitter, Instagram and LinkedIn. Additionally, Carrboro Town Council meetings are conveniently available on YouTube/CarrboroNC -- as well as the Town's legislative portal at https://carrboro.legistar.com/
How long will the development process take?
The length of the process depends on a variety of factors such as site analysis results, community engagement, site work, the RFQ process, etc. The Town Council did approve exploring the use of an expedited review process that would prioritize affordable housing projects in the Planning, Zoning and Inspections (PZI) Department while maintaining compliance. This review is technical in nature and is one of the last steps in the process, occurring after multiple community discussions and design workshops.
How will future development impact stormwater issues and trees?
The initial site analysis will include an environmental assessment which evaluates many features and issues, including stormwater and a catalog of trees and their location.
You can learn more about what's involved in a preliminary site assessment here.
What is the Town doing to further affordable housing?
The Town is actively engaged in furthering its affordable housing goals through dedicated resources and robust community partnerships and collaborations. You can learn more about the Town's affordable housing work in the FY22 Year in Review.
You can read the FY22 Year in Review here.
You can learn about the Town's latest projects here.
You can learn about the Town's affordable housing collaborations here.
Quick Links
- Site Assessment Request for Qualifications
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Last Updated 9/22/2022.


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Founder of Facebook
No one made as large an impact on how we interact in 2010 as Facebook founder Mark Zuckerberg, whom you've really gotta hand it to, as much as you'd like to punch the little shit right in his smug, 26-year-old- billionaire face. Zuckerberg launched Facebook from his Harvard dorm room in 2004 and has since seen the social network grow from a few thousand college students to more 500 million users worldwide.
Smart little fucker, isn't he?
2010 was a landmark year for Zuckerberg: He watched his net worth surpass that of Steve Jobs and of Rupert Murdoch, while also expanding his online empire to include geo-location services, high-res photo-sharing, and enhanced personalization features, all of which just proved that the redheaded little dickface has really got our number and will always have us lining up and begging for more. Goddammit.
And recently joining the likes of Bill Gates and Warren Buffett in pledging to give most his income to charity is exactly the kind of maneuver a shitwad like this would pull to make you almost respect him.
The brilliant prick's meteoric ascent has so captured the nation's imagination that screenwriter Aaron Sorkin and acclaimed director David Fincher teamed up to immortalize the little wiener in the blockbuster film The Social Network, released in October.
Though his power and notoriety are sure to grow in coming years, you really can't begrudge Zuckerberg his fair-won success, even if he looks like a pimply-faced little fuckhead you could easily kick in the balls without feeling any remorse.


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Late adds to Lei Chic's guide to the weekend's best events
Weekend Picks - Saturday, August 3, 2013
Good Clean Fun
What: As we mentioned Thursday, THEFACESHOP's third Oahu store is now open in Waimalu Plaza. What we didn't tell you is that, thanks to a larger retail space, this location offers (free!) weekend soap- and fragrance-making classes. We chose our favorites from scents and ingredients like lavender, orange, tea tree, and volcanic clay, and 30 minutes later, we had an adorable molded soap, perfectly suited for our skin type.
When: Saturdays, 10 a.m.-7 p.m., and Sundays, 10 a.m.-5 p.m., though the store is open daily.
Where: Waimalu Plaza Shopping Center, 98-1277 Kaahumanu St.
Details: Call the store at (808) 483-3773 for class information and to reserve a spot. Don't forget, your entire purchase will be 20 percent off at this location only through tomorrow.
Sale Away
What: Milk & Honey is holding a massive close-out sale as its lease inside the Blaisdell Hotel ends. The boutique has not yet found a new location, so everything must go. All apparel will be slashed 50 percent with items priced between $5-$25.
When: Today and next Saturday, August 10, noon-5:30 p.m.
Where: Milk & Honey, 1154 Fort Street Mall, #307, directions here.
Dreamy Ticket
What: This girl is on fire. First, Rep. Tulsi Gabbard was featured in Vogue. Now, the Hawaii congresswoman has been named one of The Hill's 50 Most Beautiful People. Truth be told, we never knew such a thing existed and, clicking through the rankings, we're not entirely sure how this list was compiled. Still, the honor is a cool one, as is her nickname: Hawaiian Heartbreaker.
Details: Read all about it here.
Who: J.Crew Factory
Deal: 40 percent off everything online.
When: Through tomorrow.
Who: J.Crew
Deal: 40 percent off final sale items in-store and online with the code STYLE40.
When: Through tomorrow.
Who: Juicy Couture
Deal: Extra 30 percent off sale items online.
When: Through tomorrow.
Who: Ann Taylor
Deal: $40 off full-priced purchases of $100 or more in-store only.
When: Today only.


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This article is more than 1 year old
Super-thin iMacs WILL be here for Xmas, cram warehouses even NOW
Oh Santa, you scared me! fanbois gasp
Smooth white boxes carrying super-thin iMacs are already in American distribution centres, 9to5Mac reports, pouring soothing balm on the hearts of fanbois who had previously feared that the hyper-honed desktop may be delayed until 2013.
The new iMac launched on 23 October, when Apple made much of its stir-friction welded aluminium edges. The solid-state joining process (the metal is not melted) allows a super-slim edge of just 5mm.
But a rumour from a French blog MacBidouille suggested that it was just this high-tech welding that was delaying the arrival of the machines, pushing the launch of both the 21.5-inch model and the 27-inch model back towards the end of December or the New Year.
Thankfully ANOTHER rumour - from "inside sources" who spoke to All-things-Apple site 9to5Mac this time - promised that Apple Macs would not be delayed.
The insiders claimed that both should be out, as promised, within a matter of weeks. The 21.5-inch iMac should be in stores by the end of November, with the 27-inch iMac on sale from the beginning of December.
According to 9to5's sources, the Macs are already sitting in US distribution centres just waiting to be driven out to the shops. ®


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Are Brad Paisley and Rand Paul the bravest men in America?
Er, no. At least not by my lights. But maybe the country singer and the first-term senator are contenders for that title according to the attorney general of the United States, Eric Holder.
In 2009, Holder famously declared in a speech that America is a "nation of cowards" because it refuses to talk about race "enough." What constitutes enough race talk in our private time seems like a hard thing to quantify, and I'm not sure Holder has any idea how to do it either.
Holder was hardly the first, nor will he be the last, liberal to call for a national conversation on race. It is one of the mossiest locutions in modern America. I sincerely doubt an hour goes by where the phrase or something similar — "frank dialogue," "much-needed discourse," etc. — isn't uttered or written by some editorialist, college professor or television host.
Though often ridiculous and hackneyed, this isn't necessarily a sinister or mercenary thing. It's only natural that activists, academics and consultants would want a "national conversation" on their specialty issue or cause. If your passion, principles and profits align so that you make a living from talking about race, why wouldn't you want to increase demand for your wares?
I doubt there are any activists out there who wouldn't dearly love to have their issue — adoption, literacy, animal cruelty, mopery, whatever — be turned into a "national conversation," never mind turned into a required topic in curricula from K through Ph.D.
Less defensible is when calls for a national conversation amount to a trap. It's a predictable pattern. Some poor dupe thinks people are serious about all this frank-dialogue talk. He sticks his head up to say something frank and quickly finds it separated from his shoulders.
Which brings us first to Mr. Paisley. He's released a song titled "Accidental Racist," and it has attracted an enormous amount of scorn. I can't really second-guess the music critics. It is not a great song from what I can tell. Though is it really the "worst song ever," as several critics have said? It seems to me that "Who Put the Bomp (In the Bomp, Bomp, Bomp)" is catchier but substantively less redeeming.
Which is to say that Paisley — with an accompaniment from legendary rapper LL Cool J — is striving for something important. The song is a ballad about a white Southerner trying to reconcile his Southern pride and his rejection of racism. It begins with a scene where a black barista at Starbucks takes offense at the Confederate flag on the white narrator's shirt. "To the man that waited on me at the Starbucks down on Main, I hope you understand/When I put on that T-shirt, the only thing I meant to say is I'm a Skynyrd fan."
Paisley defends the song as an effort to — you guessed it — start a conversation. Personally, I think art that has to be defended on conversation-starting grounds probably isn't art. Conversely, I'm inclined to think that any song with Paisley's message would be denounced and ridiculed. Right or wrong, letting the South off the hook for its racial sins is not something that interests many of Paisley's critics. The fact that Paisley (and LL Cool J) made the critics' job so much easier doesn't change that.
Something similar can be said about the reception to Rand Paul's appearance at Howard University this week. Here, Paul did exactly the right thing by making his case to a politically unsympathetic audience of minorities. Though, at one point, he miscalculated a bit in an exchange where he assumed his audience didn't know that black civil rights pioneers — including the founders of the NAACP — were mostly Republicans. Howard, one of the nation's premier historically black colleges, is one of the few universities where the average student probably would know that stuff.
Much of the criticism of Paul centered on speculation about his motives. He's just trying to soften his image! He's using the audience as a prop! To which the only intellectually honest rejoinder is: Maybe he is! Isn't that what politicians do?
Both Paul and Paisley are doing exactly what liberal politicians, civil rights activists and editorial boards have been demanding for decades. Paisley contributed his best effort for a "frank dialogue." Paul reached out to minorities, engaged in the conversation and didn't take blacks for granted. No one should be shocked that neither effort settled anything. That's how conversations are supposed to work, but not, apparently, the kinds of conversations the conversation-starters have in mind.
(Jonah Goldberg is the author of "The Tyranny of Clichés," which will be released in paperback April 30. You can write to him in care of this newspaper or by e-mail at: [email protected], or via Twitter @JonahNRO.)


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What's New
We've updated the app to properly support 3rd generation iPad Pro resolutions. We've also fixed several other minor bugs.
App Description
The sequel to the party game phenomenon The Jackbox Party Pack, featuring FIVE fresh, rib-tickling party games!
Games include:
1) The runaway hit bluffing game Fibbage 2 (2-8 players) with over 500 brand-new questions, more than 2x the original.
2) The hear-larious sound-effects game Earwax (3-8 players).
3) The absurd art auction game Bidiots (3-6 players), where you draw right there on your phone or tablet.
4) The say-anything, gut-busting Quiplash XL (3-8 players), which includes everything in Quiplash, Quip Pack 1, AND over 100 brand-new prompts.
5) The bomb-defusing nailbiter of a party game, Bomb Corp. (1-4 players).
Players play using their phones, tablets, or even computers as controllers – making it the perfect easy-to-join party starter. No extra controllers needed! And, spectators can join and affect some games by playing as Audience members!
NOTE: This game is local play only.
NOTE: The games included in this pack are in English only.
App Changes
- March 15, 2017 Initial release
- June 13, 2019 New version 1.1.0


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- From: frozenice <email@example.com>
- Date: Tue, 18 Dec 2012 00:36:43 +0100
- To: email@example.com
- Message-ID: <email@example.com>
-- Ryan's reply on XFF -- Yes, if we wanted to allow anon edits, we'd need to trust the XFF sent by fastly. This is also how Wikimedia's config works; see: <http://noc.wikimedia.org/conf/highlight.php?file=CommonSettings.php> -- Ryan's reply on the other thought -- Nope. The sessions are stored in memcache. No matter where the request comes from or which application server handles the request, the session will be pulled from memcache, based on the auth cookie. On 16.12.2012 04:16, frozenice wrote: > Hi, > > as I stated in my other thread from just now (called "Some Charts about WPD Users"), there was a problem with IP addresses. > > When I asked the database for unique IPs in the recentchanges table (which contains about 26k rows), > it replied with merely 18 distinct addresses. I wondered and then it struck me. > > Because we use a frontend cache (Fastly), user traffic looks like the following: > User <--> Fastly <--> WPD > > This means MediaWiki doesn't see the user's IP, but the IP of a random cache from Fastly. This effectively means > we can't block IPs in case of vandalism etc., because we would block a whole bunch of users. > > I don't know why I haven't thought of this earlier... I guess it's because I normally don't use frontend caches. > > Now, I don't know if Fastly sends X-Forwarded-For headers (it should) nor if MW can handle those. We would need > a whitelist of Fastly IPs to be trusted with the XFF header and MW would then use that value as the real IP. > > Another thought (which I can't confirm for now) is, that this could also be a source of the session issues. > > - fro >
- application/pkcs7-signature attachment: S/MIME Cryptographic Signature
Received on Monday, 17 December 2012 23:37:15 UTC


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|612 Area Code Location
|Major Cities
|Other Cities By Name


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In the 1960s, a group of researchers observed a phenomenon they called learned helplessness. In a controlled study, they used electric shocks when dogs tried to leave their cage. Later the dogs were provided a way out, but they made no effort to escape. Apparently, they had learned that they were helpless. The fact that learning disabled children may become learned helpless in academic settings has been supported by numerous studies. Continual exposure to academic failure has been shown to contribute to learned helplessness, withdrawal, unwillingness to approach new tasks, and a lack of persistence. Like the dogs in the study, they may apply this maladaptive behavior to new situations where they are capable of academic success, but think their efforts are useless.
Other factors have been shown to contribute to this learned academic helplessness. Grouping students with a variety of disabilities under the tutelage of one teacher with generic training, excessive use of external reinforcement, lack of early identification of learning disabilities, a belief in a fixed static intelligence and a lack of reward for individual effort versus achievement are all important issues to consider.
The theory of attribution
Attribution Theory contains the underlying principles by which a person decides the causes of another person's behavior These perceived causes can be dispositional and internal or situational and external. People often determine whether a behavior is dispositional or situational by using three key factors: consensus, consistency, and distinctiveness. Consensus refers to how most people act in a given situation. When consensus is low, behavior is attributed to dispositional or internal factors. When consensus is high, behavior is attributed to situational factors. Consistency refers to the degree to which people act in the same way on different occasions. Highly consistent behavior is attributed to dispositional factors. Distinctiveness refers to the extent to which people respond differently in different situations. If distinctiveness is low and people act similarly in different situations, behavior is attributed to dispositional factors. In general, if a behavior is unusual, it is attributed to the situation. If it is not unusual, it is attributed to the disposition. While this may hold true in a laboratory, people in real life are subject to many variables, so assigning attribution to any one factor is impossible.
Attribution for academic success and failure
It has been suggested that learning disabled students tend to exhibit less motivation and persistence in academic tasks. One school of thought is that academic failure is based on difficulties in the regulation of locus, stability and controllability. Self-bias also appears to play an important part in this attribution model. This model can easily be applied to children in school. The student who receives an "A" on a test may perceive himself to be bright and intelligent. The egocentric bias kicks in. He feels he was more central than may actually have been the case and is likely to be motivated to work hard for that "A" the next time. The student who receives an "F" on a test, following the same thought process of his "A" counterpart, might assume that he was central to his failure and see himself as stupid, the consequence being a decrease in motivation to study for the next test. The "F" student might, however, say things like "the teacher was biased, " "I was unlucky, " or "I didn't study," in order to avoid making a dispositional attribute of "I'm stupid." He could then view his behavior as controllable and unstable, and be motivated for the next test.
Attributions of learning disabled students
Research has repeatedly shown that children with learning disabilities make different attributions of success and failure than their normally achieving peers, and that these attributions may interfere with their classroom performance. Studies have suggested the following about academic achievement and self concept attributions of learning disabled students:
- Students with learning disabilities are more likely to make external attributions for both success and failure than their non-disabled peers. Specificallv, they are less likely to attribute success to ability or internal, controllable, and stable factors and are more likely to attribute success to luck or external, uncontrollable and unstable factors.
- Students with learning disabilities have lower global self concepts than non-disabled peers. This lowered self-concept was reported as early as grade three, and was found to remain stable through high school. Students with learning disabilities who were neither identified nor given special placement experienced lower academic self-concepts than those who were identified and specifically placed. Severely learning disabled students who received full-time special placement experienced increased academic self-concept, especially in reading.
Specific educational recommendations
Students with learning disabilities must he placed in situations where it is possible to experience academic success. The fact that 60% of illiterate adults are learning disabled is evidence of our present failure to educate this population. Early intervention is critical. As stated by Yale University professor Dr. Sally Shaywitz at a 1994 conference sponsored by NCLD in Washington, DC, "We can identify by age five which children will have difficulty learning to read and we know which teaching methods are most successful." Reading ability was chosen as a criterion for learning disability because eighty-five to ninety percent of school aged children with learning disabilities manifest specific reading or language based disabilities. It is also assumed that an inability to read would make academic success in other academic classes difficult if not impossible. Mainstreaming students with learning disabilities does not improve self-concept, but appropriate special placement and support services increase self-concept. Most teachers are not qualified to teach learning disabled students. Therefore, these students should be grouped outside of the mainstream for academic classes where multisensory and proven teaching techniques can be used. Students should continue in these academic settings until their reading levels are commensurate with their intellectual potential, and attribution retraining should begin as soon as possible. Students with learning disabilities should be taught how to set realistic goals, develop plans to achieve these goals, monitor self-behavior, and accept responsibility for goal directed activities. After specific attribution for success and failure of learning disabled students should not differ from that of their normally achieving peers.
Learning disabled students who are unable to achieve academic success can become learned helpless in academic situations. Attribution for academic success and failure can contribute to learned helplessness. If these attributions guide behavior, the attributions must be changed if behavior is to change.
Nicki G. Arnold Their World 1996/1997 National Center for Learning Disabilities