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!Quotations
The
three
great
essentials to achieve
anything worthwhile are,
first, hard work; second,
stick-to-itiveness; third,
common sense.
""Thomas Edison
I'm a greater believer in
luck, and I find the harder
I work the more I have of
it
""Thomas Jefferson

"The dictionary is the


only place that success
comes before work. work
"is the key to success

""Vince Lombardi




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"Genius is 1% talent and


"99% hard work
""Albert Einstein

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