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tifuserbar-dsavi_x4.jpg and normally with a cool mind.

(Warning: This user can be VERY confusing to some people... And talks in 3rd person for the timebeing due to how insane they are... Sometimes even to themself.)

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~D. V. "You don't want to know what crazy that was related to..." Devnull

tifuserbar-dsavi_x4.jpg and normally with a cool mind.

(Warning: This user can be VERY confusing to some people... And talks in 3rd person for the timebeing due to how insane they are... Sometimes even to themself.)

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The Hariyama Dude: Here we are, friend. Welcome to my garden.

Blaze: Wow that's a huge garden. There are a lot of [bleep]ing Hariyama. How many are there?

The Hariyama Dude: I already told you, I have over 100.

Blaze: Cool, how did you get them?

The Hariyama Dude: I caught most of them on my journeys. Mainly in Hoenn. But I caught some Hariyama in Johto and Kanto as well. Some in even Sinnoh and Unova.

Blaze: That is [bleep]ing awesome, dude.

The Hariyama Dude: Do you wanna come back inside?

Blaze: Sure.

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Dang it, iBe. I WANTED TO SUMMON OUR GOATEE-D, BALD, CAR DRIVING, EUPHONIUM PLAYIN' ALBEL.

  • Like 1

35bvvh1.png

[hide=Quotes]

Albel/Justin

Albel doesn't say anything anymore, just comes in, leaves an arrow and vanishes into the night :(Probably
practising some euphonium

You nearly had me fooled, you fooler you

Euphonium/10.

9/10. To me, always associate Albel with musical stuff in OT.

Everyone with a goatee and glasses is Albel now.

lmfao albel m8 wat r u doin, hi though.

 

[/hide]

[hide=Runescape Achievements]99 firemaking(2007), 99 woodcutting(2008), 99 fletching(2009), 99 magic(2010), 99 cooking(2010), 99 farming(2011), 99 construction(2011), 99 runecrafting(2012), 99 Hunter (2014),  99 ranged (2015), 99 HP (2015), 99 Slayer (2015), 99 attack (2015) 99 Defense (2015) 99 Prayer (2015) 99 Summoning (2015) 99 Strength(2015) 99 Herblore (2015) 99 Dungeoneering (2017)  99 Mining (2017) 99 Crafting (2017) 99 Smithing (2017) 99 Thieving (2017)  99 invention (2017) 99 Fishing (2018), 99 Divination (2018), 99 Agility (2018), MAXED (05/17/2018)[/hide]

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  • 2 weeks later...

:arrow:

35bvvh1.png

[hide=Quotes]

Albel/Justin

Albel doesn't say anything anymore, just comes in, leaves an arrow and vanishes into the night :(Probably
practising some euphonium

You nearly had me fooled, you fooler you

Euphonium/10.

9/10. To me, always associate Albel with musical stuff in OT.

Everyone with a goatee and glasses is Albel now.

lmfao albel m8 wat r u doin, hi though.

 

[/hide]

[hide=Runescape Achievements]99 firemaking(2007), 99 woodcutting(2008), 99 fletching(2009), 99 magic(2010), 99 cooking(2010), 99 farming(2011), 99 construction(2011), 99 runecrafting(2012), 99 Hunter (2014),  99 ranged (2015), 99 HP (2015), 99 Slayer (2015), 99 attack (2015) 99 Defense (2015) 99 Prayer (2015) 99 Summoning (2015) 99 Strength(2015) 99 Herblore (2015) 99 Dungeoneering (2017)  99 Mining (2017) 99 Crafting (2017) 99 Smithing (2017) 99 Thieving (2017)  99 invention (2017) 99 Fishing (2018), 99 Divination (2018), 99 Agility (2018), MAXED (05/17/2018)[/hide]

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R.I.P Shiva and The Old Nite

Visit My Huge Goals!!! <---- Click This

My Pk Gallery

supdefnubew6.png

GWD: 3x Saradomin Sword, 2x Saradomin Hilt, 2X B Boots, 1x Tasset, 2X B Plate, 2X Shard, 1X D Med

TDs: 3x Solo Claws, 1x Solo Armour Piece

99 Untrimmed HP, 0% Pc'd and before Soul Wars -- Trimmed July 1, 2009

First Untrimmed HP Cape to 96 summon, top 300 to 96 summon

Proud owner of the strength, magic, range, and hitpoints capes.

Spa_Ins/LOLCANADA on IRC.

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  • 2 weeks later...
  • 4 weeks later...
  • 5 weeks later...

Case 2:

Summary of case:

Innovative new design that was a significant improvement; however, risk of strut failure

identified in clinical trials, likely due to manufacturing flaw. Shiley insisted risk was small; FDA

approved in 1979 based on honour system. As lawsuits arrived, Pfizer (which bought Shiley) filed

for secrecy documents to prevent access to incriminating data. Eventually pulled from market in

1986, but only after over 82000 valves had been implanted. Investigations in 1987 found

company documents which included the falsification of manufacturing information. In 1990,

FDA informed Shiley to notify patients of the flaw in the device, but only after further research

did Shiley eventually accede.

Ethical issues identified:

·

Shiley withheld data from clinical trials from the FDA

·

Shiley falsified manufacturing process documents to make it appear that manufacturing

flaws were being corrected while they actually were not.

·

Shiley was aware that it was selling a faulty device, but did not pull it from the market until

much later (possibly thought that the risk of failure not high enough to warrant such an

action?)

What could have been done better to protect rights of the patient:

·

Should FDA have approved the device in the first place based on its honour system? (FDA

had approved previous Shiley valves; also issue of additional cost to FDA of performing own

research)

·

Shiley should have released clinical trial data to the FDA

·

In order to continue selling the device, Shiley should have at least rewelded the cracked

valves instead of only polishing them (falsified manufacturing documents stated that cracked

valves were being rewelded and polished before distribution; in reality, no rewelding was

occurring).

·

Once the FDA informed Shiley to notify patients of the device flaws, Shiley should have

done so immediately instead of waiting for more information to arise.

Another example of a harmful medical device is the Bjork-Shiley convexo-concave heart valve,

produced by the company Shiley Inc. (and later Pfizer after it bought Shiley in 1979). Prosthetic

heart valves are often used to replace defective heart valves, and in 1971 Shiley designed and

marketed the Bjork-Shiley plano-convex heart valve. While successful, it was prone to

thrombosis, and in an attempt to rectify this flaw, Shiley came up with a new convexo-concave

design. This innovative new design was a significant improvement over the previous

plano-convex design, reducing the risk of thrombosis and allowing for the manufacturing process

to be sped up.

However, in early clinical trials, Shiley discovered that struts in the heart valve, used to support a

disc vital to its function, had a notable risk of failure, most likely due to flaws in manufacturing

6Ij0n.jpg

In real life MMO you don't get 99 smithing by making endless bronze daggers.

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