text:
New Drug Reviews
Alirocumab (Praluent) for the Treatment of Hyperlipidemia
Am Fam Physician. 2016 Aug 15;94(4):310-311.
Alirocumab (Praluent) is a monoclonal antibody labeled for the treatment of hyperlipidemia in patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who need additional lowering of low-density lipoprotein (LDL) cholesterol despite treatment with diet and maximally tolerated doses of statins.1 It is one of two inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK-9), a protein that binds LDL-receptors on hepatocytes, leading to enhanced clearing of serum LDL by free LDL receptors.
|Dose form
Alirocumab (Praluent)
75 mg via subcutaneous injection every two weeks, increasing to 150 mg every two weeks if needed
Prefilled 75-mg or 150-mg syringe/pen
*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed July 6, 2016).
|Dose form
Alirocumab (Praluent)
75 mg via subcutaneous injection every two weeks, increasing to 150 mg every two weeks if needed
Prefilled 75-mg or 150-mg syringe/pen
*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed July 6, 2016).
In an 18-month randomized controlled trial, 2,341 patients taking alirocumab did not have increased all-cause mortality, cardiovascular mortality, stroke, or heart failure compared with those taking placebo.1,2 Alirocumab has been shown to increase adverse neurocognitive effects such as amnesia, memory impairment, and confusional state, but these are rare (number needed to harm [NNH] = 170). Serious adverse effects leading to discontinuation are similar to those with placebo and are infrequent (7.2%).
Common adverse effects of alirocumab include localized injection-site reactions, nasopharyngitis, and flulike illness (4% to 11%).1 Additionally, myalgia is more common with alirocumab than with placebo (NNH = 40). When alirocumab is used alone, one in 20 patients will discontinue therapy because of adverse effects. However, when combined with maximally tolerated statin therapy, pooled drop-out rates totaled 28% with alirocumab vs. 24% with placebo (NNH = 25).
1. U.S. National Library of Medicine/National Institutes of Health. Drug label information. Praluent–alirocumab injection, solution. https://www.dailymed.nlm.nih.gov. Accessed December 28, 2016.
2. Robinson JG, Farnier M, Krempf M, et al.; ODYSSEY Long Term Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015;372(16):1489–1499.
STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.
This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.
A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.
Copyright © 2016 by the American Academy of Family Physicians.
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text:
we just upgraded our Spiceworks 3.6 to 4.0 this morning. But after updating the spiceworks-finder.exe consumes up to 100% cpu load while running network health checks or scans and the adminportal stopps responding while this occurs. When the scan is over, everything goes back to normal behaviour.
Most bugging is that while the spiceworks-finder.exe is running, the system even does not respond to user-mails and tickets so that some incidents might get lost.
Is there a fix/workaround?
Jun 22, 2009 at 9:49 UTC
akp982 is an IT service provider.
- Stopping spiceworks
- deleting everything in c:\program files\spiceworks\log\
- Starting spiceworks
This topic was created during version 4.0.
The latest version is 7.5.00101.
17 Replies
Jun 22, 2009 at 9:37 UTC
I have exactly the same issue, just posted about it actually. I've tried fresh installs and everything. Still stalls during the network health scans.
Hopefully there is a workaround.
Jun 22, 2009 at 9:44 UTC
We are going to disable the health checks and network scans or at least turn them on only in non-working hours until the problem is fixed.
Jun 22, 2009 at 9:49 UTC
akp982 is an IT service provider.
- Stopping spiceworks
- deleting everything in c:\program files\spiceworks\log\
- Starting spiceworks
Jun 22, 2009 at 9:58 UTC
OK, thanks, I´ll try it.
But I will report tomorrow and not today. In germany it´s time to pack in right now ;-)
Jun 23, 2009 at 2:05 UTC
OK, has worked for now.
Thanks for the answer. The CPU load is still 100% from spiceworks-finder.exe, but the adminportal is still responding during the network scans.
Jun 23, 2009 at 4:01 UTC
akp982 is an IT service provider.
The spiceworks-finder.exe works its arse off when doing a scan, but it will run quicker now it doesn't have to deal with all the 10mb logs...
Jun 23, 2009 at 7:42 UTC
Bad news:
Has worked until this afternoon. But now: Same issue again.
This morning the network scan and the admin portal was still responding. And now since 2 hours the same problem as yesterday occurs: 100% cpu load and the adminportal stopps responding.
Jun 23, 2009 at 7:48 UTC
akp982 is an IT service provider.
... Bummer ...
Ill flag a dev see if they have any ideas, there have been a couple of problems like this
Jun 23, 2009 at 9:41 UTC
How large is the production.log right now?
Please send us your log files.
Jun 23, 2009 at 10:00 UTC
it´s 1.962 kb right now.
I´ll send the package.zip right now
Jun 23, 2009 at 12:24 UTC
We have found the cause of the problem, it is when we are saving the network map data at the end of the scans and it will be corrected in the next patch release.
Until that time you will need to either turn off or decrease the frequency of the Network Health Check, and the regular Network scan if it is also causing a problem.
:^) Harold
Jul 24, 2009 at 3:12 UTC
1st Post
And when will the patch be released ?
Because when the scanning need te be frequently running in our company, and it should not use 100% CPU load.
Any solutions ?
Greetings and thanks in advance
Jul 24, 2009 at 11:11 UTC
You can download the update (version 4.0.37242) from our website.
Aug 4, 2009 at 1:03 UTC
Are you guys seeing the spiceworks startup take 100% CPU for 75-90 seconds aswell? I'm only havign problems with one of our two spcieworks boxes. After clearing the logs as described above and upgrading the version all the events in the startup log show they happened within 2 seconds, not pointing to the CPU spike and launch delay. Also seems to spike when the scan is not active but the status says "computing network map". As for the scan usage, it seesm to be all over the place. When you click the scan button the CPU pegs and stays for a minute, then drops, then 50 seconds later pegs for 30, then up and down as I would expect.
Aug 4, 2009 at 1:11 UTC
akp982 is an IT service provider.
This will be due to your logs...
- Stop spiceworks
- Create a folder c:\program files\spiceworks\log_old
- Move everything from c:\program files\spiceworks\log to that folder
- Start spiceworks...
warning spiceworks will find it harder to support you if you need to send them your logs
Aug 4, 2009 at 2:36 UTC
I did purge the logs. As that was a few hours ago I have since had a few starts/stops/scans and the total folder size is 263KB, so I do not think that is the source of the problem.
Aug 13, 2009 at 12:47 UTC
I'm still having this same issue... even after upgrading to the latest version - 4.1.39136. It happens every time it does a network scan or health check.
This discussion has been inactive for over a year.
You may get a better answer to your question by starting a new discussion.

subset: commoncrawl


text:
Working Mom Blogs
a wife, mother, teacher and photographer. I've learned living with Celiac disease isn't.. all that bad. My kids are my heart, my blessings. I am a child of God. I trust in Him. I rest in.. Him. I believe Him. My writings come from my experien
Owner: heidigraves
Listed in: Parents
Other Tags: family, photography, celiac, gluten free
2. Lap Noodles
I needed an outlet for my thoughts that might allow me to reclaim some parts of my old identity.. while I figured out this crazy life that is no longer really mine.
Owner: Tumbleweed
Listed in: Parents
Sometimes I find myself going crazy! I will be sharing crazy things my kids and hubby do, as well as.. some random thoughts. I plan to share some recipes, craft ideas, and who knows what else.
Owner: tandvjung
Listed in: Parents
Other Tags: Colorado, SAHM, Army, Fort Carson
Mom returns to work after 5 years by starting a small business and embraces her life, family, and.. community as well. Lifestyle musings and planning tools and business and work related templates for.. the working woman.
Owner: myoch
Listed in: Personal
Other Tags: life, family, small business, enterpreneur
I work. I mom. I confess.
Owner: martiarocker
Listed in: Parents
a site about working women on family & money matters,health &community issues,saving.. ideas,etc.
Owner: leilaj
Listed in: Parents
Other Tags: family issues, money saving ideas, parenting& money management
I empower working moms to live their best life by sharing tips on career and personal development,.. parenting and healthy living. I am an avid foodie!
Owner: workingmommy
Listed in: Parents
8. kimberliah
The story of me... a working mother/wife, as told by the voices in my head.
Owner: Kimberly_Warren
Listed in: Humor
Other Tags: family, special needs, ADHD, funny
A very unconventional blog from a working mom and active duty military member. Moms come in all.. shapes and sizes this one happens to be only 5'3 and super opinionated.
Owner: msvip213
Listed in: Parents
Other Tags: unconventional parenting tips, potty training for boys, top mom blog, finding humor in life
10. The Bean Blog
Trying to stay sane while raising five kids, going to college part-time and working full-time.
Owner: thebeanblog
Listed in: Parents


text:
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Welcome to
St Peter's Wellesbourne
Parish Website
Here you should be able to find all the information about St Peter's Church and our sister parish, St James's Walton D'Eivile.
St Peter's Wellesbourne:
inspired by Jesus to forgive, encourage and serve.
Harvest Services: Harvest 2017
New Contact for Church Centre Bookings: Church Centre Bookings
Connections service- Following a successful initial trial, we have decided to continue the new Connections informal worship service indefinitely. It takes place in the Church Centre, running concurrently with the service in the church building, every Sunday at 10:15am. For further information follow the following link: Connections
Alpha Course - The next Alpha Course starts with an Alpha Supper at 7:30 pm on Thursday 28th September; see Alpha Course
How Healthy is our church life: 8EQs results communication 26may16.pdf
St Peters' Annual Report - Annual Reports
The Fosse Foodbank has opened in Kineton, for more information: Fosse Foodbank


text:
Food Products
Company Overview of Annie's Homegrown, Inc.
Company Overview
Annie's Homegrown, Inc. produces food products. It offers pastas, snacks, soups, frozen snacks, baked items, dressings, condiments and sauces, and special diet products. The company offers its products through retail stores in the United States. The company was founded in 1989 and is based in Berkeley, California. Annie's Homegrown, Inc. operates as a subsidiary of General Mills, Inc.
1610 Fifth Street
Berkeley, CA 94710
United States
Founded in 1989
Key Executives for Annie's Homegrown, Inc.
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text:
WE have just come home from our two week stay at the Grand Paradise Hotel in Puerto Plata!!!! We arrived on Sunday April 14 and left on Sunday April 28, 2013....This is our 5th time to the hotel and I must admit that there is more than one reason we keep coming back!!!
Firstly.....THE STAFF!!!!
When you walk in the door you are greeted by the Hotels bellhops who always have a great smile (and because we've been there so often, a big hug), then off to the reception area where our friend DAMARYS, a young lady who really knows her stuff, had everything ready for us without any hesitations. Our room wasnt ready upon our arrival, we kind of anticipated that seeing as we had arrived so early, but it was no big deal, there is a huge, clean, bathroom where we were able to get changed and commence our holidays. Off to the bar we went to say "Hi" to the fimiliar faces. There are so many names I want to mention, but some have slipped my mind, anyhow, GUILLERMO was the first to spot us and came out from behind the bar to give us hugs and welcome us "home", our drinks were a little strong, but by the end of your holidays, you dont even notice...lol...at night we often retreated to the Extasis Bar by the pool for our "entertainment" of the night. If youre looking for broadway or Las Vegas shows, this place isn't for you, rather the entertainment staff go above and beyond to make you either part of their show or ensure you are enjoying their show. CHISPA is our main man!!! He is so good at what he does, and he rarely forgets a face!!! He's very warm and isn't afraid to join your table at lunch or come hang out with you during slow times. We are very hopeful to see him again in October!!! DONKEY is new and we didn't really get to now him like CHISPA, however his EMCEE skills are pretty remarkable, he knows how to get the crowd going. Our bella, BONBON, the "towel girl" was so sweet to us, everyday she worked, she made sure to come and say good morning to us and offered excellent service at all times!!! Our favourite bartender would have to be OSWALDO and his sidekick JOSE. Never did our glasses go empty when he was working, they always made time to ask how we were, OSWALDO has become like a brother to us....he sure is missed!!! The staff in the main dining area are prompt and at your beck and call. We were with a larger group and they had our table set and reserved at all meals, which was nice during the weekend when the Local people came to enjoy thier country. The A la Cartes haven't changed, the staff is awesome there!!! I wish I had written names down now!!! Make sure to seek out SPEEDY, the water sport coordinator!!!
There was much more variety this time around which we were grateful for as we were spending 14 days there. There was a different theme every night, if there you can't find something you like, then you too picky. At times there were line ups to wait to enter the dinning hall, but I can only see that as being a good thing...that means more and more people are coming back. The A La Cartes could use a change up of the menu, the food is okay, to be honest, id rather eat at the buffet, just my opinion, I invite you to form your own.
CLEAN!!! Our room was cleaned in the afternoon, which I thought was pretty perfect, and our cleaning lady was tooooo cute...she left fancy things made on the bed all the time. Our fridge was stocked with water and pop every day. We stayed in an Oceanview Suite, the sound of the ocean put us to bed every night.
The beach at this resort is like nowhere else in the Playa Dorada complex. It's clean, and huge. There are reefs not far off the shore where we saw a Lion fish, plenty of beautiful striped fish, Blue "Dory" fish and a great big old crab. Let me take a minute to talk about the vendors, or the "blue shirts" as you may have heard, yes, they can be a pain in the butt, everytime you turn around there is someone trying to sell you something, but listen, these people don't make a lot of money, the job availability there is low so they bust their butts trying to make a couple bucks to support their families. These vendors PAY a fee to be allowed to sell on the beaches. You can barter with them, their all very friendly and if you low ball them, they'll laugh it off and walk away. Or a simple "NO GRACIAS" keeps them moving too. BTW the stuff sold on the beach can be purchased at the Plaza"Cheapy Cheap", probably half of what they want on the beach. Anyhow, it's just part of the experience!!! And if you're looking for a good booking agent on the beach for Excursions, request to speak to either Gilberto or Hector (the protector), they have good prices and yes you are covered by insurance, their company is the same company that Nolitours books their excursions through.
YEah that was a crappy deal...it has become quite expensive and you can no longer log out to save your remaining time. I think that there have been enough complaints about that, I'm sure that when we return in October, their internet system will be a better deal for those of us who need to use it to communicate with our children.
Overall our time there is never money wasted, I am already counting down 5 months and 19 days until our next trip there...hope this helped you make a decision, I can honestly say that if you go with an open mind and normal expectations, that you will have a remarkable time!!! Hasta lleugo!!!
- Reservation Options:
- TripAdvisor is proud to partner with Booking.com, Hotels.com, Orbitz, Expedia, TripOnline SA, Cancelon, Hotwire, Travelocity and getaroom.com so you can book your Grand Paradise Playa Dorada reservations with confidence. We help millions of travelers each month to find the perfect hotel for both vacation and business trips, always with the best discounts and special offers.
- Also Known As:
- Grand Paradise Playa Dorada Hotel Puerto Plata
- Paradise Beach Club Puerto Plata
- Paradise Beach Resort Casino
- Paradise Beach Puerto Plata
- Paradise Beach Club Casino


text:
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he Mercedes-Benz G-Class or G-Wagen (as it was called from 1979 to 1994), short for Geländewagen (or cross-country vehicle), is a four-wheel drive vehicle / sport utility vehicle (SUV) produced by Steyr-Puch (now Magna Steyr) in Austria for German automaker Mercedes-Benz
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text:
Avery Lane is driven to discover the fate of the 117 missing colonists of Roanoke. When she encounters a mysterious group called the Descendants, who are determined to keep the colony's secret hidden, Avery must choose between her obsession for the past and her own survival. Will solving this mystery cost her everything? Is there more to this secret than what is buried at Roanoke? Haunted by visions of the past, she must find answers before the Descendants stop her and forever banish the truth.
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Fictional Answer to a Historical Question
A Review of audiobook Roanoke Vanishing by Auburn Seal Narrated by Caprisha Page Auburn Seal has written a very interesting theory of the fate of the roughly 115 colonists who settled on Roanoke Island in 1587 only to disappear without a trace. Avery Lane, a student trying to write her thesis so that she can graduate, has chosen the story of the settlers as her topic. Unknown to her there were/are? people who did/do? not want the truth to be discovered and broadcast to the world. A group of these people made it nearly impossible and extremely dangerous for Avery to research her topic, endangering her friends in the process.Auburn Seal has written this story in alternating time between 1587 and the present in a chapter in the present and a chapter in history very effectively. You must listen to Caprisha Page's audiobook presentation of Auburn Seal's Roanoke Vanishing. It is an experience you want soon forget. It also, might make you think about so called facts on which our history is based.Who was Virginia Dare? Google it. What happened to Virginia Dare? Listen to Roanoke Vanishing.
Yes. It kept me wondering what could possibly hinder this girl's research next.
Caprisha, in her own special way of presenting a story, has managed to keep me interested in the story and amazed at her character representations. Caprisha is a unique storyteller. I look forward to hearing more of her narrations. Perhaps in this Vanishing Series of Auburn Seal's.
Yes, if you have nine hours to spare and a nice comfortable chair.
This is an audiobook you absolutely must add to your library.
- Hubert Williams
Super awesome!
I really liked the way that the historical facts were woven into a great fantasy.
I don't read a lot of historical fiction, but the bigger mystery felt a bit like A Great and Terrible Beauty.
She does an excellent job overall. She reads too slow, however, once I sped up the narration it was fine. She does the voices of the ladies particularly well.
Yes, of course. Sadly I have children and a job pressing on my time.
Absolutely recommended!
- Amazon Customer


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text: Lululemon AthleticaAnother potential earnings short-squeeze trade idea is designer and retailer of technical athletic apparel Lululemon Athletica ( LULU), which is set to release its numbers on Thursday before the market open. Wall Street analysts, on average, expect Lululemon Athletica to report revenue $343.10 million on earnings of 35 cents per share. Just recently, Citi analyst Oliver Chen started coverage on shares of Lululemon Athletica with a buy rating and a $90 per share price target. He said the company's sales productivity is at $2,000 per square foot, vs. Michael Kors at $1,500, Coach at $1,800 and Tumi that is above $1,200. Chen thinks Lululemon ales can reach $3,000 per square foot, as LULU gains brand recognition and expands from current 60% penetration in the U.S. The current short interest as a percentage of the float for Lululemon Athletica is extremely high at 20%. That means that out of the 133.71 million shares in the tradable float, 20.81 million shares are sold short by the bears. The bears have also been increasing their bets from the last reporting period by 7.5%, or by about 1.45 million shares. If the bears get caught pressing their bets into a bullish quarter, then shares of LULU could explode higher post-earnings as the bears rush to cover some of their short bets. From a technical perspective, LULU is currently trending above its 50-day moving average and just below its 200-day moving average, which is neutral trendwise. This stock has been trending sideways for the last month and change, with shares moving between $74.75 on the upside and $67.70 on the downside. A high-volume move above the upper-end of its recent range could trigger a big breakout trade for LULU post-earnings. If you're in the bull camp on LULU, then I would wait until after its report and look for long-biased trades if this manages to break out above some near-term overhead resistance levels at $72.71 to $72.82 a share and then once it clears more resistance at $74.75 a share high volume. Look for volume on that move that hits near or above its three-month average action of 3.34 million shares. If that breakout triggers, then LULU will set up to re-fill some of its previous gap down zone from June that started at $82.50 a share. I would simply avoid LULU or look for short-biased trades if after earnings it fails to trigger that breakout, and then drops back below its 50-day at $69.29 a share and then once it takes out more key near-term support at $68.50 to $67.60 a share with high volume. If we get that move, then LULU will set up to re-test or possibly take out its next major support levels a $63 to $62 a share.


text:
176 pages, 206 colour photos, colour maps
The Arctic National Wildlife Refuge (ANWR) is America's Serengeti, comprising 19.8 million acres of land in the northeast corner of Alaska and adjoining Ivvavik and Vuntui National Parks in the Yukon Territory in Canada. Photographer Subhankar Banerjee, in collaboration with six essayists, presents a portrayal of a unique landscape made up of equal parts beauty and hazard. The Arctic National Wildlife Refuge, one of the last intact ecosystems on earth, is being impacted by forces that may change its existence forever: global warming and the encroachment of modern society through the potential for oil drilling.
Jimmy Carter, George Schaller, and Bill Meadows narrate the story with essays that delve into the history of the Refuge, the political battles – past and present – and the fragility of the ecosystem. Wildlife biologist Fran Mauer writes of the areas geological and geographical uniqueness while Debbie Miller describes the cultures of the Inupiat Eskimos and the Gwich'in Athabascan Indians. David Allen Sibley explores the prolific bird life and migrations at the refuge with an eye toward the delicately balanced ecology of the region. Peter Matthiessen, reflecting on his journey through the Refuge with Banerjee, passionately defends the need to preserve these lands and the people and the wildlife they shelter.
"[...] Through this book, Banerjee wanted to show why this area should be forever set aside and left undeveloped. He succeeded. This book is particularly recommended to those who aren't aware of or don't understand the reasons to oppose the drilling for oil in the Arctic National Wildlife Refuge. But even if you are well versed in the debate this book will still take you on a breathtaking journey through this special place."
– Grant McCreary (15-04-2008), read the full review at The Birder's Library
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text:
*OFFICIAL* Windsor Spitfires 2012-13 Season Thread (Part 8)
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Join Date: Sep 2010
Posts: 10,314
vCash: 500
[QUOTE=RayzorIsDull;59900921]Well Taylor Hall refused to play for Erie. I am not sure if Erie would have drafted Hall 1st overall, OReilly was really talked about going #1 from day 1.
Ryan Ellis had an offer from Ohio St, not sure how serious was that.
Watson was pretty much a cooked deal, knew a day before the draft they were going to take him and "hope" he would show.
Fowler I can see how somebody would say it was cooked.
In regards to Hall and Ellis the team wasn't good before they showed up and had very little to sell prospective picks.
I think what you saw earlier was those type of picks wanted to make an impact and put Windsor on the map. Now you see like you say entitlement and certain players just along for the ride. After this week I think the offseason needs to begin now. Rychel and the scouts need to pound the pavement and start drafting better.[/QUOTE
Hall actually was not coming to Windsor initially either,despite the fact Riolo was gone for 1 year
As for Watson USNTP took too long so he came to Windsor
While some think it was a cooked deal for Fowler it was not
You are correct Windsor was not a good team prior to Hall and Ellis arriving,coming off their 1st draft with Nemisz,Henriques,Cundari,Wellwood,Hackett, draft
Year 2 had a50 pt improvement tied for 1st,Mickey tragically passes away
We know what happens after that for years 3 and 4-Mem Cups BTB,
No doubt scouting and management have to do their jobs going forward
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Boris Valejo
IronUppercut 2 September, 2014 at 15:38 2
Boris is among my favorites. Since I was young and I saw some of the video game covers he has done such as Splatterhouse 3, I have loved his style. One of the best in the world of fantasy art.
Musicalchemist 31 May, 2015 at 09:15 2
One of the first art books I ever bought in my life was a Boris Vallejo & Julie Bell book called "Titans" a collection of superhero artwork. Boris has one of those instantly recognizable styles, much like how one quickly identifies a Norman Rockwell piece. I would place him among one of the finest artists in terms of how well he does human bodies. The attention to detail is staggering.
Rob the Fox 24 January, 2017 at 17:12 0
Very well done.


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EER Band D
Delightful and charming main door ground floor conversion
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EER Band D
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text:
- Fujiko using her bikini top to zipline down to a boat in the first episode.
- Fujiko's ridiculous orgasm noises while having sex with Zenigata at the start of episode 4. Also Oscar chewing out some policemen for listening in outside the door.
- Fact Zenigata of all people, beat Lupin to sleeping with Fujiko
- Zenigata firing at Lupin in episode 4. Blood goes squirting out of Lupin's chest, only for our loveable larcenist to turn around and start spraying Zenigata with fake blood from a pump inside his shirt. Oscar then comes up through a trap door, which hits Zenigata in the face, knocking him out. Oscar turns around to see the man he loves lying on the ground, covered in blood. He then picks him up and does a Skyward Scream.
Oscar: Inspector! Oh, you're drenched in blood! What a decadent beauty! I mean, no! Please wake up! Inspector!!
- Goemon dressed up as Fujiko in the final two episodes.


text:
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
Product ID: 704848
- 20
- September 2017
Duration: 90 Min
Customer Care
Fax: +1-650-565-8542
Email: firstname.lastname@example.com
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
Why Should You Attend:
Software and related hardware design, development, verification and validation is difficult to manage, document and control. This presentation will focus on the documentation required by the U.S. FDA for the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing cloud-based software.
A suggested field-tested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus of the webcast is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS / 21 CFR Pt. 11. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
Areas Covered in the Webinar:
- Major industry failures
- Tougher FDA expectations / requirements
- Roles of verification and validation
- The 11-element FDA model - and where it's required
- A typical software V&V protocol / test report
- A brief overview of 21 CFR Part 11, ER / ES
- Legacy, hybrid, new, and cloud systems
- Expected regulatory deliverables
- Complementary guidelines, e.g., GAMP
Who Will Benefit:
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- Production
- Engineering
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- All personnel involved in a U.S. FDA-regulated environment
- Those involved in new product development with products and equipment that are software driven
- Companies with quality management / MRP / ERP systems moving toward paperless systems or other regulated medical products activities
John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company, with over 33 years' experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process/ product/ equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. He is a graduate of UCLA.
Topic Background:
Software/ firmware design and development is under increased scrutiny by the new tougher U.S. FDA. Recently a major pharma company paid a $750 M fine for poor compliance, and software V&V was one of the key contributors.
Product, production/ test equipment, and even the QMS are heavily software/ firmware driven in today's manufacturing. A comprehensive, corporate wide plan is a necessity. Growing cloud issues add urgency to upgrade control. Software's complex logic pathways mandate resource-intensive V&V activities, in a resource-constrained environment. Risk-based software documentation is the answer. What are the best approaches for companies to take? How can tougher FDA expectations be met? What V&V is necessary to minimize software failures in the field or in-house? How to bring software V&V in under budget and within project timelines?
More Trainings by Expert
10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance
Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
Change Control - Implementation and Management
Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
Documenting a Risk-Based Quality System - for Compliance and Cost-Savings
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Donald Trump wants Americans to dump their iPhones and MacBooks.
The Republican frontrunner for President unleashed a series of tweets on Friday calling for the boycott after the company's decision to fight a court order calling for it to hack an iPhone used by the San Bernardino shooter.
"I use both iPhone & Samsung," he wrote to his more than 6 million followers. "If Apple (aapl) doesn't give info to authorities on the terrorists I'll only be using Samsung until they give info."
He added in another tweet, "Hopefully others will follow suit. Our country needs & should demand security. It is time to get tough & be smart!"
In a third, he wrote, "Boycott all Apple products until such time as Apple gives cellphone info to authorities regarding radical Islamic terrorist couple from Cal"
The call to boycott Apple comes days after Trump, along with fellow candidate for President Marco Rubio, criticized the company for its decision.
"I agree 100 percent with the courts—in that case we should open it up. I think … we have to open up, and we have to use our heads," Trump said in an interview on Fox News.
Meanwhile, one Twitter user made the point that despite his call for the boycott, his campaign had a merchandise table set-up with iPads to pay for merchandise.
The news comes as Apple has been named No. 1 in Fortune's 2016 World's Most Admired Companies franchise list.
Fortune has reached out to Apple for comment, and we will update this post once we hear back.


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text: Politics 29 January 2007 Identity crisis Irish Freedom: the story of nationalism in Ireland Richard English Macmillan, Sign up for our weekly email * For anyone interested in the Northern Irish situation, the history of nationalism in Ireland is essential to trying to make sense of what has happened there. As Richard English states in his introduction, nationalism has shaped the modern world. It has caused and fuelled wars, stabilised and destabilised states, and defined political and cultural life across the globe. In nationalist thought, the collective will of the community expresses itself in legitimising the nation as the proper and free political unit. For nationalists, self-determination is a central political right. Some historians hold that nations are ancient, perennial or even primordial, others argue that they are in fact modern creations that began in the 18th century. English argues that there was no single, original Gaelic or Irish race. With the Northern Ireland peace process in mind, he rejects the idea of a pure Irish race opposed to Protestants who are less truly Irish. Nevertheless, he shows that the establishment of a national church in Ireland in the seventh century did create the idea of an Irish nation. That idea was strengthened by the arrival in Ireland, in August 1170, of the Norman earl Richard FitzGilbert de Clare (known as Strongbow). This invasion, which was sanctioned by the pope, began the long subjugation of Ireland. In the centuries that followed, ideas of Irishness underwent many changes. By the 16th century, the Reformation had failed to take root in the country and Catholics were seen as the true Irish. But it was a Protestant, Jonathan Swift, whose pamphlets collected as The Drapier's Letters helped to form the idea of an Irish people - or "imagined community", as Benedict Anderson famously put it. The pamphlets, which protested against a patent granted by the English for the coining of debased halfpence, were widely read and celebrated. Although he writes well about Swift, English argues that the author's deep ambivalence about Ireland excludes him from the category of founding fathers of Irish nationalism. The next important influence on the idea of an Irish nation was Edmund Burke, who in the 1790s supported the enfranchisement of Catholics and their right to be admitted to parliament. He was an enthusiast for the redress of Catholic grievances and the advancement of Catholic power. Importantly, English argues that Burke should not be seen simply as a conservative polemicist against the French revolution - he helped to give shape and direction to the idea of an Irish nation. This trend was countered by the Protestant patriotism of the late 18th century, followed by the Society of United Irishmen, who drew on the French revolution, Rousseau and Paine for the ideas that fuelled their unsuccessful attempt to establish a republic in 1798. In his memoirs, their leader Wolfe Tone wrote: To subvert the tyranny of our execrable government, to break the connection with England, the never-failing source of all our political evils, and to assert the independence of my country - these were my objects. To unite the whole people of Ireland, to abolish the memory of all past dissensions, and to substitute the common name of Irishman in place of the denominations of Protestant, Catholic and Dissenter - these were my means. In the 19th century, Irish nationalism took a non-violent turn under the leadership of the Dublin lawyer Daniel O'Connell, who secured Catholic emancipation. But shortly after his death, the Irish Republican Brotherhood was formed. The movement achieved nothing, but it kept the idea of physical force alive. It was the physical force of the IRA in the 1916 uprising that destroyed constitutional nationalism, and the subsequent execution of its leaders that made moderate politics appear unworkable, with the result that Sinn Fein swept the board in the 1918 general election. As English shows, nationalism has a cultural life, too - Tom Moore's melodies, the Nation newspaper, the Young Ireland poets, Yeats's poems and plays and the Abbey Theatre all contributed to building the idea of an Irish nation. But one theory, popular for a time in the 1980s, is that there are really two Irish nations - one Catholic Irish, the other Protestant Northern Irish. English has no truck with this idea - he is, he says, an agnostic when it comes to nationalism - but his prose warms to the challenge that the Ulster unionists mounted to traditional Irish nationalism. "Unionists could claim as much moral sanction from democratic legitimacy as their nationalist rivals," he writes of their 1912 mobilisation to oppose the Third Home Rule Bill. Beyond that, one of their chief leaders, Edward Carson, believed deeply that Ireland could only be truly happy and prosperous within the United Kingdom. Like many unionists, he held that nationalist Ireland was culturally isolationist, economically backward, would-be tyrannical, Romish in religion and constricting of Protestant, British liberties. In recent years, Irish nationalists have begun to accept that they must recognise unionist culture as a significant and enduring part of the national idea. This is symbolised by a step taken by the Sinn Fein Lord Mayor of Belfast, Alex Maskey, in April 2003. Along with senior members of the British army, Maskey attended a service in Belfast's St Anne's Cathedral to commemorate the First World War dead. Maskey's own grandfather had fought in that war, and on Remembrance Day he laid a wreath at the City Hall Cenotaph. Though English doesn't mention them, similar symbolic gestures have taken place in the Irish republic, which failed to honour the dead of both wars for many decades. English's survey of what in Ireland is an obsessive subject shows how important family lore and group life were for the formation of the mulch of emotion, imagination and political theory that is modern nationalism. It is a stimulating and learned study that deserves to be widely read. Tom Paulin is lecturer in English at Hertford College, Oxford Subscribe from just £1 per issue This article first appeared in the 29 January 2007 issue of the New Statesman, Climate change More


text:
found a new home!
Plenty of my friends are looking
for one too. Find a pet to adopt.
I am already neutered, housetrained, a special needs pet, up to date with shots, good with dogs, and good with cats.
Since I was found on the streets, I have been to the vet a few times: I am now neutered, had some rotten teeth removed and had my heart looked at. It turns out that I have a heart murmur, but aside from taking a pill twice a day, you wouldn't even know it!
I'm looking for a quiet type of home - I'm a little scared of lots of human commotion. But whenever my foster family has friends come over, I hang out in my favorite bed in my crate and I am happy as can be!
If you are interested in finding out more about Matty, please fill out an application on our website by copying and pasting the following link into your browser:
Matty is being fostered in Worcester and the adoption fee is $100.
"LIKE"; Broken Tail Rescue on Facebook!
NOTE: Visual breed identification in dogs is unreliable, so for most of the dogs we are only guessing at predominant breed or breed mix. We get to know each dog as an individual and will do our best to describe each of our dogs based on personality, not by breed label.
We expect that all adopted dogs will enroll in a formal dog training class with their new owners. Obedience and training classes are an excellent way to learn more about your newly adopted dog, gain handling and training experience, and improve your relationship with your pet.
Matty, a Worcester Chihuahua/Terrier (Unknown Type, Small) dog was adopted! Here's how you can benefit by looking at adoption as an option to buying a Chihuahua/Terrier (Unknown Type, Small) for sale in Worcester, or seeking a Chihuahua/Terrier (Unknown Type, Small) dog from a breeder in Worcester.


text:
This isn't to say that ROSI or measuring security in qualitative terms isn't valuable. Of course it is; we want to stop bad things and we want to know that our security solutions are working effectively. But it is worth contrasting these two approaches to better understand how ROSI and ROI can be leveraged when trying to justify budget, align the security budget with business priorities, and do all this while still focusing on risk reduction.
Qualitative measures: ROSI
There are very specific investments that can be made in security that reduce risk and are also measurable in terms of dollars; we'll get to those in the next section. However there are also a number of subjective measures that while more qualitative, are important variables in determining the health of an organization's security posture.
Consider washing your hands - it's probably a good idea for my kids to wash their hands when they get home from school. While I know it is a good idea, and they know it too, even though their first instinct is to turn on Phineas and Ferb and turn the remote control into a Petri dish, I would have difficulty associating a monetary measure with them washing their hands at that instance even though it know it might help me avoid medical bills, missed school, etc. Switching back to security, some examples of ROSI include:
- Enhanced ability to prevent malicious activity
- Improved incident detection to incident remediation threat window
- Enriched decision making predicated on more exacting security data
- Increased efficiencies when generating reports to placate auditors
- Fewer compromised assets engaging in C2 communication
All of these ROSI examples are highly relevant. They make intuitive sense and are for the most part inline with the philosophy that many security experts use to validate what they do and why they many need more money and resources to do it. But depending on the organization, assigning actual dollar values to these bullets may be extremely difficult. Also, if your organization isn't as security aware as you might wish, and they still think about computer security in terms of locking up your floppy disks, you may need to provide them with some more tangible monetary measures.
Quantitative measures: ROI
The examples given under the ROSI section might not fit into one of the many concise ROI formulas such as: (Gains from Investment – Costs of Investment)/Costs of Investments = ROI. And if that ROI is positive we generally see this as a good investment. If that ROI is negative, we generally see this as a bad investment; as in you don't want to spend $100 on a $1 issue. There are other variables that must be considered for an accurate calculation such as adjusting for the timing of a positive or negative cash flow to allow for the time value of money. But that's beyond the scope here and you get the general idea without having to pull out a financial calculator.
Security isn't often thought about in terms of making money or saving money, but it can be. More organizations are asking their security teams to align with their business priorities and as such provide ROI measures. Here are a few use cases that illustrate how it can be used.
ROI example 1
Taking advantage of security suites and APIs that integrate products across vendors may yield the following gains:
- Using fewer security solutions and vendors
- Minimizing vendor product training for technical staff
- Reducing duplication of efforts
- Achieving greater purchasing strength by purchasing more from fewer vendors
All of these items in example one can be directly measured in terms of dollars. For example, we may save a million dollars a year in maintenance just by moving from seven security vendors to four security vendors and taking advantage of integrated suites and vendor partnerships to provide an equally strong if not stronger security posture. We might cut $100k in training costs, and move two FTEs that were doing essentially the same thing as two other FTEs on a different product onto other tasks. And or course the more you spend with a singe vendor, the deeper the discounts.
ROI example 2
Enriching existing security controls with solutions focused on making what you've got – better is a great ROI measure. There is often a push, by vendors, to sell you the latest and greatest control to stop the latest and greatest attack. In many organizations they've got the tools already, they just need to improve upon them; sort of like putting a supercharger in your 4x4 so you can tow that boat to Lake Tahoe without a minivan passing you. Some examples include:
- Getting three more years of life out of a five million dollar SIEM solution by linking it to big data security analytics solutions
- Using threat feed services integrated into your perimeter controls to reduce the number of malicious sites your employees visit and as such reduce the number of systems that need to be re-imaged
- Empowering your existing IPS and network-based anti-malware solutions to actually see encrypted traffic crossing the network through SSL decryption tools
In example two the dollars saved by not having to rip and replace existing infrastructure can be measured and the value gained, as in example one, also contributes to reduced risk.
This is somewhat analogous – and by somewhat I mean a pretty big stretch – to the cooking show Chopped where chefs are given a basket of ingredients and told to use what's in the refrigerator and pantry to make it better. Most organizations aren't trying to decide if they need firewalls, IPS, and anti-malware solutions. What they really need are solutions that improve on what they've got and in doing so improve ROSI and ROI.
How are your organizations going about this discussion? Is security simply being asked to reduce risk, or is security being asked to align with business priorities and demonstrate ROI?
This article is published as part of the IDG Contributor Network. Want to Join?


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Marian Martin 9458; ca. late 1960s or early 1970s; Misses Dress, Sleeveless with Short and Long Sleeve Options.
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With iOS 10.2 released this week, Apple introduced a series of changes to the iOS. While the headlines around the new iOS centered around availability of new emojis and the new TV app, Apple has made some much desired changes in its Music app among other things.
With the iOS 10 earlier versions, it was hard to locate the shuffle/repeat options on the music app. In 10.2, the directions are little clearer. When you first update your iPhone to iOS 10.2 and access the Music app, the app shows you how you can access these functions. Wish we had this clarity when trying to figure it out in iOS 10.
iOS 10.2 Music App – Quick Tips
Simply swipe up on the screen to access Repeat, shuffle and Up Next functions.
In iOS 10.1, you had the option to Sort Songs and Albums in the Settings area. When you tapped on Settings > Music , you could choose Sort Songs & Albums and choose by Artist or by title in this section.
This option has been now changed in iOS 10.2. Tapping on Settings > Music shows you only the Genius option in the Library section.
RELATED : Apple Music Not Working, How-To Fix
In order to set up the sort order in iOS 10.2, you will need to access this feature within the app itself as opposed to Settings.
From your main Library screen in the Music app, tap on Songs. You will find the Sort function on top right corner of your screen. Tap on Sort and you can choose to select the sorting either by the Title or the Artist.
The same options hold true for Albums as well and you can change the sort order by tapping on the Sort button.
In the case of Playlists, you can now sort either by the Playlist Type, Title or Recently Added.
These options to sort were not readily available in iOS 10.1 variants earlier.
With any new change, it does take a while getting used to. What do you think about the subtle changes introduced in the new iOS 10.2 Music app? What are some of the changes that you would like to see in the Music app moving forward?


text:
Yakuza Graveyard (1976) DVD ISO
From The Director Of Battle Royale And The Yakuza Papers. One of maverick Japanese director Kinji Fukasaku's (Battle Royale, Cops vs. Thugs) "darkest thug-operas" (Village Voice), Yakuza Graveyard is a gritty, brutally violent action film, a mature, poetic achievement in personal filmmaking, and a trenchant x-ray of xenophobic post-war Japanese society. Tormented by guilt and embroiled in a literal dead-end affair with a woman he widowed in the line of duty, renegade Detective Kuroiwa (Tetsuya Watari -- Tokyo Drifter) is the one-man definition of "rogue cop." When his corrupt superiors assign Kuroiwa to the organized crime beat, they inadvertently pull the pin on a gun-toting human hand-grenade. Violating his "hands-off" orders, Kuroiwa plunges fists first into the Nishida gang yakuza underworld. And when he meets Keiko (70s Japanese action film icon Meiko Kaji -- Lady Snowblood, Female Prisoner Scorpion), the beautiful half-Korean wife of an imprisoned Nishida boss, Kuroiwa finds himself risking much more than just his badge. Outlaw cop and gang-moll become both lovers and unwitting pawns in a brazen, police-sanctioned yakuza power-grab conspiracy. As Kuroiwa is forced to choose a side, the stage is set for betrayal, degradation and massacre. A story of personal depravity, national racism, and romantic self-sacrifice, Yakuza Graveyard takes its place alongside Oshima's In the Realm of the Senses and Shohei Imamura's Vengeance Is Mine as one of the handful of spectacularly graphic and accomplished downward spiral films of 70s Japanese cinema.
Yakuza Graveyard (1976) PAL DVD9
IMDb Link: http://www.imdb.com/title/tt0075441/
Genre: Action / Crime / Drama
Distributor: Rapid Eye Movies
Year: 1976
Country: Japan
Director: Kinji Fukasaku
Source: DVD9 Retail
DVD Format: PAL
DVD Size: DVD9
Programs Used: ImgBurn
Video Bitrate:
Screen Format: Widescreen 2,35:1 (16:9)
Audio Language: Japanese
Audio Format: DD 2.0
Subtitles: German, English
Menu.: [x] Untouched
[ ] Stripped
Video: [x] Untouched
[ ] Re-encoded
DVD Extras: [x] Untouched
[ ] Re-encoded
[ ] Stripped
[ ] None on source
Uploader's Comments:
DVD Extras: Trailers, Interview with Mark Schilling (German Questions & English Dialogue)
These files can all be downloaded at Usenet.
Get 14 Days for free Access to USENET. Free 300 GB Unlimited downloads!


text:
enRoute Magazine by Air Canada: Discover the Contenders for Canada's Best New Restaurants
""Progressive Latin" sounds like a bookish tag line, but there's plenty of playfulness at this humble Kitsilano neo-bistro."
Food Rebublic: Where to Eat and Drink Now in Vancouver, BC
"Jefferson Alvarez and Marcela Ramirez entertain guests on the daily with lunch, dinner and drinks steeped in south-of-the-border flavors met with progressive techniques. Opt for the Journey Tasting menu, a seven-course steal at $75..."
Westender: Cacao delivers a five-star dining experience
"Well, this is nice: My first review of 2017 is about a restaurant where I had one of the best meals of the past year. Twice."
Georgia Straught: Dine Out Vancouver Festival's World Chef Exchange brings together top culinary talents
"The chefs come in and showcase their cuisine and their style, and we can be really playful with that," he says. "It's also a great opportunity to learn, for me and for the diners.
EAT Magazine: Vancouver Buzz: January
"Chef Jefferson Alvarez is finally in charge of his own kitchen where he can show his passion for latin flavours and dishes. Brunch is more traditional with breakfast selections and some risottos and pasta dishes. Dinners have a fusion of latin flavours and ingredients. "
Globe & Mail: Adventurous eats define Vancouver's dining scene in 2016
" They're marinating vegetables in blobby, kombucha scoby (Cacao) "
Vancouver Sun
"Jefferson Alvarez is one of the more innovative and daring chefs in this city, and his cooking is more in line with the world's edgier cuisine."
Globe & Mail: Best New Restaurants 2016: Vancouver
"This uncommonly innovative restaurant is already defying expectations and breaking delicious, new ground."
Georgia Straight
"Progressive Latin means we are always developing... We are rying to do as many Latin flavours as we can…one dish can have three different continents."
Globe & Mail 2016 Review
"Mr. Alvarez is returning to his South America roots while incorporating the modernist twists and more holistic local trends he has accumulated along the way"
Scout Magazine
"Chef Jefferson Alvarez explore(s) his penchant for "Progressive Latin" fare, which is to say modern takes on pabellon, toasted arepas, Brazilian BBQ, grilled octopus, ceviche and more with beer, cider, wine and cocktails to drink."


text:
Need Appliance Repair Help? Ask a Technician for Answers ASAP
Hello, and thank you for using this service. I'll be helping you with your problem today.To start, this error means that the washer isn't draining properly. Unfortunately these washers are not easy at all to access and fix a drain problem. There is a drain catch inside the washer that you will want to access and clean if you're getting this drain error. To access the drain catch, it's very difficult. The top panel, the control panel, and the entire front panel all need to be removed so that you can access the pump below the tub. It's really a bad design and it was never this difficult in the past, but now there is quite a bit of work involved to clear the drain so unless you're really handy, this is not something you'll want to tackle yourself.To access the drain pump, you need to pull the washer forward and unplug it. Pull the dispenser drawer completely off the washer. Next, remove the 2 bolts coming in from the back of the top panel. The top panel will pull straight back, up, and off. Remove the screws coming in through the dispenser opening and the screws coming from the inside of the washer going into the control panel. The control panel will then pull up and out of the way. At this point, you just have a few screws going across the top of the front panel to remove. Tip the wash back a bit and there are 2 screws in the bottom right and left corner you need to remove.Since the door is locked, there is a plastic tab hanging from the bottom of the latch assembly. You need to unplug the washer and pull down on that plastic tab to manually unlock the door. You'll need to reach in from the top of the washer and if you're not tall or have long arms, you may need a stick to help pull down on that plastic tab to unlock the door.Open the door and you need to disconnect the rubber door gasket. There is a wire ring around the front lip of the rubber door gasket. Use a flat head screwdriver and pry the wire ring off the gasket. Now you can remove the front panel to access the drain pump located under the drum attached to the drain catch.
We are on the honor system here. Please remember to rate my service by selecting a star at the top of the screen before you leave today. If you need anything else, just let me know. You can continue asking follow-up questions at no additional charge after rating my service if you still need assistance.
Hello again. I'm just following up because I haven't heard back from you and I see this question is still open. Is there anything else I can help you with?


text:
We can help you to locate a bassoon teacher in Cambridgeshire and across the UK. First Tutors: Music profiles Cambridgeshire bassoon tutors and others offering popular instruments like piano, violin and guitar. Grade and diploma bassoon tuition are all catered for across Cambridgeshire as well as bassoon tuition just for fun. Please use our service to search for bassoon tutors near you and select which bassoon tutors best suit your requirements.
First Tutors: Music is the best place to find the most talented bassoon teacher for your needs in Cambridgeshire, whether you want bassoon lessons to learn a new instrument, develop a hobby or improve as a musician.
We list bassoon tutors in your area according to their charges and distance from you. Instruments include, but are not limited to, piano, violin and guitar for graded music exams or just for fun.
If you are a Cambridgeshire bassoon tutor wishing to offer your bassoon tuition services in Cambridgeshire or anywhere else across the UK, please register with First Tutors: Music to commence giving bassoon lessons or find out more about us here.
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text:
I also wear glasses
Most Helpful Guy
Do it like Beckham
would look sick if you had even lighter blonde00|00|0
I also wear glasses
Do it like Beckham
would look sick if you had even lighter blonde
Have an opinion?
Uh, could I have a picture maybe? I'm not being a creeper, you tots don't have to.
Its just that a good hairstyle depends on your face structure, face shape, the size of your eyes, your nose, your mouth, even your skin color and eye color...
If you really don't want to send a picture you could just explain it to me. But its a load easier with a picture.
Love a simple ponytail, and like it better if ur going casual to wear a baseball cap with ponytail pulled through the back of cap
I would say strait and short cut
Straighten it and put like a curl at the end of ur hair i honestly think tht would be cute Especially with a girl with glasses
You cannot undo this action. The opinion owner is going to be notified and earn 7 XPER points.


text:
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- PC Games and Downloads
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Step into the dark and mysterious world of "Ninja Blade," where gamers will be given the epic task to defend Tokyo and ultimately humanity itself from a horrific, genetically mutating disease.
High atop the towering skyscrapers of modern-day Tokyo, Ken Ogawa and his team of skilled ninjas are deployed to destroy the infected monster horde and stem the spreading disease as humanity hangs in the balance. Matters quickly take a turn for the worse as Ogawa and his team are betrayed from within their own ranks. After narrowly escaping death, Ogawa is left to fight the daunting battle alone while also attempting to understand the motivations behind his father's betrayal.
Armed with an extensive arsenal of specialized ninja weapons, tools and skills including the powerful forces of Ninja Vision and Todomé Attack, players must fight insurmountable odds, and once again bring peace and order to Tokyo.
Ninja Blade on Xbox 360 Features:
- Unique ninja abilities. To help defeat the genetically mutated monsters, players will have the special abilities of Ninja Vision and Todomé Attack at their fingertips. Enabling Ninja Vision will allow players to detect and analyze potential enemy weak points, secret paths and hidden information within the environment. Beware, though, that while using Ninja Vision, characters become susceptible to excess damage. Todomé Attack is a special attack that destroys an enemy character's core (heart), by dealing a fatal wound. Balanced and calculated use of both these abilities will be critical to progressing through the game.
- Variety of weapons, tools and Ninjutsu — specialized Ninja powers — offer an enticing array of options. Varied environments force players to think strategically about which set of weapons and tools will be most effective at conquering their way through different levels. Everything from dual-wielding swords to grapple wire hooks and grenades has distinctive features and characteristics, so choose wisely! Ninjutsu is a special power that results in an explosive electrical force to either stun enemies or protect oneself from attack. Only true Ninja Masters can achieve this technique.
- Interactive quick-time events. Scattered throughout integral parts of the storyline, characters will come across various quick-time events where players will have the opportunity to directly interact with in-game cut scenes. Quick reflexes will be rewarded as players interact with controller buttons as directed on screen during intense battles.
- Modern realism. "Ninja Blade" offers a fresh twist to the classic ninja saga by basing all 3-D gaming maps directly from the actual skyscrapers and building tops in modern-day Tokyo.
Pegi Rating:Suitable for people aged 16 and over.
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Churchill's Alysheba Stakes next target for Giant Oak
STICKNEY, Ill. – Chris Block is a Chicago man through and through. His family, which races as Team Block, is a leading owner and breeder in Illinois, and the heart of Block's season as a trainer is the Arlington Park meeting. But at the moment, Block has more high-level stakes horses than at any point in his career, and to accommodate them he has opened a small division in Kentucky for the spring and early summer. Block, just after saddling first-time starter Knightfiester, who won Hawthorne's first race on Saturday, said he had five stalls secured for the Churchill Downs spring-summer meet. Four of them will be occupied by stakes runners Never Retreat, Askbut I Won'ttell, Mister Marti Gras, and stable star Giant Oak.
Giant Oak, winner of the Donn Handicap and third last out in the New Orleans Handicap, worked a half-mile in 49 seconds at Keeneland on Saturday, a day before he was scheduled to move to Churchill. Giant Oak's 49-second breeze was nothing remarkable time-wise, but Block said the horse had galloped out strongly, and was doing well.
"I'm excited about him," Block said.
Giant Oak is scheduled to race on Kentucky Derby Day in the Alysheba Stakes. Block and Chicago-area owners Rudy and Virginia Tarra hope to get Giant Oak to the Stephen Foster Handicap in June.
Shake N Quake steps up in sharp form
There is plenty of strong current form in the featured eighth race on Tuesday at Hawthorne: Four of the seven fillies entered in a second-level Illinois-bred sprint allowance were winners of their most recent race.
Shake N Quake tops that quartet of last-start winners. Though she beat only $17,500 conditioned claimers on March 30 at Hawthorne, Shake N Quake was a middling stakes runner in 2009. The fact that trainer Jim DiVito (11 for 27 so far this meet) boosts Shake N Quake back to allowance competition suggests the filly really is back on her game.
The problem is that Shake N Quake's game is speed, and there are others in the race who also prefer the front end. A fast, contested early pace could set things up for Raspberry Jam. Raspberry Jam has raced on or near the lead in two recent claiming-race wins, but has run equally well from off the pace, and enters Tuesday's race on a serious roll.


text:
- Refreshing lavender scent
- A perfect way to start the day
- Size - 25 oz/735 ml
Personally, I find showering with Lavanda Puig bath gel to be the perfect way to start off my day. When you lather up with this refreshing gel/soap, its fresh and pungent aroma of lavender blossoms fills the room!
The aroma of lavender is a refreshing tonic from the mountains of the Mediterranean. Roman baths were scented with lavender. The word comes from the Latin word lavendum, "fit for washing." Since the beginning of civilization in Spain, it has provided a sensation of well being. Why not enjoy the aroma of lavender in your own home?
Aqua(water), sodium laureth sulfate, cocamide dea, cocamidopropyl betaine, peg 32, sodum chloride, parfum(fragance), sorbitol,polysorbate-20, polyquaternium 7, citric acid, methychloroisothiazolinole, C.I. 19140 ( yellow 5) and C.I. 42090 ( Blue1).
All information listed on our website, including nutrient content information, ingredient lists, and information relating to health claims is for informational purposes only and not provided as medical advice. You should carefully read all information in the actual product packaging and labels, including for food allergen, nutrient content and qualified health claims before using or consuming a product. La Tienda does not assume any liability for inaccuracies or misstatements about products.
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Customer Reviews
"Always great!! The aroma brings memories of my childhood..."
M. Antonia Iglesias - Tacoma, WA - Jul 12, 2016
"A mi este gel me trae auténticos de recuerdos de casa,gracias por acercárnoslo a un tiro de ratón."
Currita de la Cruz - BOSTON, MA - Jan 19, 2016
"This the most marvelous body wash gel. Unlike conventional American consumer products it just doesn't smell "like body wash". It's lovely herbal, lavender aroma makes it as though you are showering in a mist of delightful cologne. Highly recommended."
Rufus T. Firefly - NY, New York - Jul 8, 2012
"I love this product. The scent is kind of a spicey Lavender, fairly unisex but probably women would like this best. It lathers up well with just a small amount and has an energizing scent that fills the room but doesn't have a strong lingering scent. The large bottle lasts and lasts. Great product for the price. "
Lavender fan - Mar 29, 2011


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Tehran, Iran, Nov. 30
By Mehdi Sepahvand – Trend:
Iran's sovereignty over three islands in the Persian Gulf is not negotiable, said member of Asian Parliamentary Assembly (APA), Ali Kazemi.
Kazemi made the statement on the sidelines of the APA General Assembly in Cambodia in response to recent claims by UAE officials, ICANA news agency reported November 30.
He rejected as false claims the recent statements by a member of the UAE Federal National Council, but noted that Tehran is ready to hold talks with the UAE to "resolve misunderstandings."
He went on to condiment the Emirati lawmaker's claim as against international law, the UN charter, and good neighborhood manners.
In the last decades, there has been tension over three islands in the Persian Gulf: Abu Musa, Greater Tunb, Lesser Tunb.
UAE challenges Iran's sovereignty over three islands in the Persian Gulf, while Iran considers them as its inseparable parts.
The islands have been in Iran's control since 1971 following the departure of British forces from the Persian Gulf and few days before UAE's declaration of independence.


text:
Depending on the year of the BMW, outside mirrors were either secured to the door panel or the window frame.
To remove a door mounted mirror, unfasten the retaining screws securing the mirror to the door. If the mirror is remotely attached to the interior door panel, the bezel and control cable will also have to be removed.
To remove a mirror attached to the door window frame, proceed as follows:On some later 5, 6 and 7
Series models with the speakers in the triangular panel, the speaker(s) must be unplugged. Be careful not to puncture the speaker or grille when removing the trim panel.
- Remove the mirror mounting trim on the interior of the door by pulling it off towards the rear. On later 3 Series models, the panel is pulled off from the top after the top is pull out slightly.
- Support the mirror and remove the retaining bolts.
- Disconnect the harness plug and/or speaker plug, if equipped then remove the mirror.
- To remove the mirror glass, insert a thin tool into the opening at the bottom, center of the mirror. Rotate the locking ring to the outside of the mirror to remove. Carefully pry the glass out of the mount clips at the bottom edge.
- Install the mirror and connect the plug. Install the mounting trim.


text: I think this is the first Crimson Peak cosplay I've seen, but starting off with Lucille and Thomas Sharpe is never a bad thing (with a special appearance by Edith's mother!). These photos from Tumblr user Octobass prove that good fashion never goes out of style. Check out more photos of these awesome costumes below.


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This guitar is no longer for sale (sold on 2007-02-17)
Price : US $821
This is a very nice vintage Yamaha CJ-838S II acoustic guitar.
It was made in the late 1970s or early '80s and is a rare deluxe model Yamaha acoustic. It has a jumbo body (J200 style) with solid spruce top (I think the ''S'' in the model number denotes solid wood) and the back and sides are made of rosewood, or some other similar hardwood, and also appear to be solid. The body measures 16 9/16'' wide at the lower bout and 12 1/4'' wide across the upper bout. Body is 4 3/4'' deep. It has a mahogany neck, a bound ebony fingerboard with pearl block inlays and an ebony bridge.
The headstock is bound with a rosewood overlay and pearl YAMAHA logo with pearl diamond inlays. The top and back have 6 ply binding. The back has a fancy center stripe (see photo). This guitar is all original and and in very good condition. It has some normal minor nicks, scratches and pressure marks but nothing too severe and overall very nice, clean and extremely attractive. There are no cracks, breaks, repairs or problems. The top is flat and the bridge and neck joint are tight. This guitar plays and sounds great even with the old strings. The neck is very straight with good action and normal light fret wear. Includes chipboard case. Very Nice vintage Yamaha CJ-838S II jumbo acoustic guitar in very good condition. Rare.
This guitar is sold (sold on 2007-02-17)
Post a comment on VINTAGE YAMAHA CJ 838S II ACOUSTIC GUITAR :
tony j said...
Bought mine 2nd hand in 1971/2, so it could be older than you think - brilliant guitar
bruce pittman said...
i have one for sale
Joe said...
I own one - nice..


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You've already got 5 items in your shopping cart, so there's no room to reserve another one. If you'd like, you can take something out of your cart to make room for this one.
Plot Summary
Plot: Colonel Terry Childers is a 30-year Marine veteran: a decorated officer with combat experience in Vietnam, Beirut and Desert Storm - a patriot, a hero. But now, the country he served so well has put him on trial for a rescue mission that went terribly wrong. For his attorney, he has chosen Marine Colonel Hays Hodges, a comrade-in-arms who owes his life to Childers. Hodges is not the best lawyer in the service, but Childers trusts him as a brother Marine who knows what it's like to risk death under fire. Bound by duty and friendship, Hodges reluctantly takes the case, even as he begins to doubt the man who saved his life in Vietnam three decades ago.
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"Last night I got a confirmation that the recipient received the cake and greeting card. I'm so glad that you solved the problem. I was considering for the next year to look for another company, but as you took care about the reported issue, surely I will come back to you for your services. Thanks a lot. Keep doing a good service, and take care of this kind of issues for future customers."
Gabriela A - Guadalajara, Mexico - Sep 21, 2015
"For a long time, I searched a website to send a gift to my friend in China. Finally, I found this one with excellent reviews. Well, I am not deceived : excellent service, reliable, recommended 100% and my friend was delighted. For sure, I will use their services another time."
Liudmila - Novocherkassk, Russia - Mar 18, 2013
"You guys are seriously AMAZING. I order a lot of flowers internationally and you are the absolute BEST!"
Ronda - El Cajon CA, USA - Oct 16, 2015
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