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The NFL continues to crack down on defenders who use the outlawed "horse-collar" tackle, and Chicago Bears middle linebacker Brian Urlacher has been fined $7,500 for an incident in last Sunday's loss to the Minnesota Vikings.
Urlacher is the second Bears' defensive player sanctioned this year for the illegal maneuver, which was banned in 2005.
Rookie defensive back Corey Graham was fined for using a horse-collar tackle in a Sept. 30 game against Detroit. He has appealed the fine.
The ban against the horse-collar technique is often referred to as the "Roy Williams Rule." The Dallas strong safety came under scrutiny during the 2004 season for repeated use of the horse-collar technique, in which a defender grabs an offensive player on the back of his shoulder pads and yanks him down.
In studying the tackle, the NFL's competition committee concluded that it had contributed to several lower extremity injuries in 2004.
On the play for which he was fined, a run by Minnesota tailback Chester Taylor midway through the second quarter, Urlacher was not penalized by game officials. But the NFL officiating department, in reviewing videotape of the game, determined that Urlacher's hit on the play constituted a horse-collar tackle.
Urlacher will likely appeal the fine.
Len Pasquarelli is a senior writer for ESPN.com.


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Below are top resources on SparkPeople for Being Healthy At Work.
I'm sure you have heard people say, "Losing weight is easy. Keeping it off is the hard part."
Well, I disagree with this statement. I think losing weight is hard, but keeping it off is even harder!
Permanent weight... Read more
Christina (CFOSTER1966) lost 97 pounds and says she started this journey to become healthier and to ward off the complications that come with obesity. She has maintained her weight loss for the past 18 months. Find out how she did it!
... Read more
I love motivational quotes. One of my favorites is, "Whether you think you can or you can't, you're probably right!" I believe that there is a lot of truth to that statement. As a runner, I know that if I focus on the fatigue... Read more
It cannot talk yet it speaks to you. Some days it makes you giddy with delight. Other days it puts you into a deep depression. It judges you on a superficial level. The thought of it is enough to worry even the most optimistic person. What am I talki... Read more
Here are more thoughts and testimonials from the community, our SparkPeople members.
From LDWADDLES
I've tried eDiets, Weight Watchers, TOPPS and never seemed at home. Somehow, I feel more at ease here and I have not explored mo... Read more
Whew 8 min on treadmill at 2.5 and I am wiped out. Gotta work on this more.... Read more
Staying on track at work is the most difficult! #firstpost #avoidthecandyjar... Read more
Working on loosing another 6 inches and few pounds just need to focus just need my back to cooperate.... Read more
Well here I am at the end of my first day! It went well. How often do you weigh yourself? I don't want to get discouraged. Do you think once a week?... Read more
#friendfinder I am looking for a motivational partner who shares the same goal as me! I weight 152 pounds and my goal (for right now) is 140 pounds. We can keep each other updated and check in on each other! Please reply if you need one too!ð... Read more
These work by replacing your old thought patterns with new ones that are more positive and productive. The reason you struggle to lose weight is because you have deeply ingrained habits that are holding you prisoner. Youve done the same thing for so... Read more
When I am in a funk, not wanting to do the work required for this healthy lifestyle, I make myself sit down and log on to Sparkpeople. I go to my Sparkpoints page and start working my way through it. By the time I am halfway done, I am ready to take... Read more
This group is for college students who are looking to get healthier and need a little support from those in a similar situation... Read more
As we express our gratitude, we must never forget that the highest appreciation is not to utter words, but to live by them. ~John Fitzgerald KennedyIn a few short days many of us will gather around the table with family and friends to give thanks for... Read more
I always thought when I lost all my weight somehow my life would be perfect. I would finally be able to accept myself for who I was. I would no longer find fault with myself. I would be able to go into any store and buy anything I wanted right off... Read more
4 Oz salmon
1/2 cup broccoli
1/2 cup califlower
1/4 cup brown rice
1/4 cup scrambled eggs
Sea salt and pepper to taste
All steamed in the microwave at work
Hot green tea to finish it off... Read more
Ok, I know its it's not fun to talk or think about work on a Monday, but.... it is better to be healthy enough to work!
I am lucky to have a job I like and the flexibility of self-employment. That does mean, though, that if I'm not workin... Read more


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I truly believe that international education can change the world. From studying abroad, hosting exchange students, working abroad, doing international internships, taking international classes, learning languages, taking a gap year, asking questions and learning about people's lives, and traveling, there is a plethora of ways to learn about people, places, cultures, and
Kids today face challenges that their parents and grandparents could never imagine. There are no clear career paths for them, because the way we work and live is constantly changing and evolving. This has also created opportunities, and a lifestyle, that didn't exist a decade ago. Now, more than ever, kids can truly live their dreams. They can create
Many view history as a dry subject to study with visions of dust clouds rising from giant tomes. But this is hardly history's reality. History is vibrant and alive; we can touch it and see it ourselves. Right now in the 21st century. Today.
"Canada is food, and the world is better for it."
~ Anita Stewart, Food Laureate at the University of Guelph and Food Day Canada Founder
In just under two weeks, athletes from around the world will be marching into Maracanã Stadium in Rio de Janeiro, Brazil, carrying their nations' flags.
When you think New York City, what comes to mind first? Central Park, of course (or, if you're our daughter, Central Perk, and THEN Central Park).
One of our national treasures, Central Park was our nation's first public park – and has remained free since its creation.
Provence. Idyllic, quiet, peaceful. Known for its incredible scenery, scenery which has inspired countless artists and poets over the past few centuries. Renowned for its comfortable tradition of home cooked food and fresh produce. Dipping its toes in the Mediterranean, it stretches all the way to the foothills of the towering French Alps. With art, culture, scenery, fine cuisine, and a host of tiny villages to explore, the Provençal region is without a doubt one of the greatest road trip destinations in Europe.
Marie is passionate about travel and languages. She is studying Translation, Interpretation, and Intercultural Management in Paris. She speaks French, Spanish, and English fluently and is currently learning Italian and Breton. Marie's goal is to speak as many languages as possible, mostly learning them by travelling around the world.
Context, organizer of critically acclaimed walking tours, expands to its 38th worldwide destination with the launch of a new Stockholm program.
Lords and Ladies of West Michigan, save room on your calendars for the Black Rock Medieval Fest, held on 5 weekends in summer in Augusta, Michigan. The festival runs from 10am - 6pm on weekends, July 9th through August 7th.
Wandering Educators


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Hotel Arena, Isla Holbox
- Free WiFi
Main amenities
- 7 guestrooms
- Near the beach
- Bar/lounge
- Air conditioning
- Daily housekeeping
- Limited hour front desk
- Tour/ticket assistance
What's around
- Main Square (0 mi / 0 km)
- Holbox Church (0 mi / 0.1 km)
- Passion Island (1.3 mi / 2.1 km)
- Punta Mosquito Beach (1.4 mi / 2.2 km)
- Yalahau Lagoon (1.4 mi / 2.3 km)
For families
- Private bathroom
- Free toiletries
- Daily housekeeping
- Hair dryer
Hotel Arena, Isla Holbox
Hotel Info: 866-539-8117from $50
- Standard Room with Balcony, Town View, 2 Double Beds
- Suite, Town View with Balcony, 1 King Bed
- Standard Room, Courtyard View, 2 Double Beds
Also popular with travelers from the USA
At a glance
Key facts
Hotel size
- This hotel has 7 rooms
- Check-in time starts at 3 PM
- Check-out time is noon
Required at check in
- Credit card or cash deposit required
- Government-issued photo ID required
Travelling with others
- No cribs (infant beds)
- Pets not allowed
- Free WiFi in public areas
- Free WiFi in rooms
Nearby Two Star Isla Holbox hotels
In the hotel
- Bar/lounge
- Front desk (limited hours)
- Tours/ticket assistance
In the room
- Air conditioning
- Ceiling fan
- Private bathroom
- Free toiletries
- Hair dryer
- Free WiFi
- Daily housekeeping
- In-room safe
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Reservations are required for massage services and can be made by contacting the property before arrival at the number on the booking confirmation.
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Hummer H2 Stretch Limo
Crown Limousine offers you the easiest way to book the ultra-luxury hummer limo for Napa-Sonoma tours and travels.Read More
Mercedes GL AMG Limo
This limo, by far, is one of the rarest limos not just in the Bay Area but in the U.S. Crown Limos is proud to present this posh,Read More
Range Rover Stretch Limo
Range Rover Limo Rental Napa / Napa wine country is one of the the best in the worldRead More
Party Bus for Napa-Sonoma
Make the transportation of a large group of people enchanting for Napa-Sonoma by Crown Limousine.Read More
Welcome to Limo Service in Napa
At Crown Limousine, our mission is to offer the best and affordable service so that customers experience best comfort during tours and travels. We have years of experience in arranging the most appropriate transportation for the event transportation such as weddings, birthday parties, proms-formals and bachelor-bachelorettes. We can also arrange the best vehicle for making your wine tour, casino tour, sightseeing and sports trip memorable and enjoyable. We are also efficient in arranging the sophisticated and classy vehicles for the corporate travels, airport transportation and pickups or drop-offs. We can fulfill all your transportation-related requirements in the easiest way. We offer our services for Napa-Sonoma, Calistoga, Rutherford, Saint Helena, Yountville, Santa Rosa and Healdsburg.
Wine Tour Service in Napa:
Wine Tours are speciality, wine tours in Napa can be arranged in variety of our vehicles. From SUVS, to stretch SUV, to party buses, we do it all.
Hummer Limos in Napa:
Our luxurious limousine selection includes Escalade and Hummer limousines, which are truly magnificent due to their classy look and lavish interior. The Lincoln 6-14 passenger limos, which are the hybrid version of the legendary Lincoln Town Car, can also be booked for the transportation through us. These limos can provide best accommodation for up to 20 passengers.
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To provide the solution for all your transportation-related worries, we have included the best party buses in our fleet. Our selection includes remarkable 18, 20, 24, 30, 36, 40, 50, and 55 passenger party buses, which can easily accommodate a large group of passengers. The party buses have a high quality interior with wet bars, PlayStation 3, karaoke machines and dance poles for the entertainment of passengers. These party buses are favorite transportation of many people for city tours, tailgating events, proms-formals and bachelor-bachelorettes. Sedans and Limos: We offer you the amazing SUVs, town cars and shuttle services for the airport transportation. You can find many amenities and features in these SUV limos that can make your travel ultra-comfortable. You can comfortable rent these sedans along with Chrysler limousines and Lincoln limousine for local commute and event transportation.
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Wedding limo services in Rolls Royce, Bentley, Mercedes is also our specialty. We are one of the only limo companies that offer these services in Napa-Sonoma and in the Bay Area.
Prom Limo Rentals in Napa Sonoma
We also offer the best service that includes pickups and drop-offs to or from hotels, bus stands and Bart-stations. We offer dedicated service to make your commute to the local or distant casinos remarkable. For the corporate customers, we offer commendable billing service at the competitive rates. We have recently introduced the Christmas light tours to enjoy the holiday decorations and twinkling lit houses. Exotic Cars: We can arrange the exotic cars that have self-driven facility through our reliable rental companies to provide you the unique travel experience. Some of the world-class exotic car brands that can be booked through our network are Mercedes, Range Rover, Rolls Royce Phantom, Ferrari and Lamborghini. Always remember to call Crown Limousine for booking or renting a limousines, party buses or exotic cars in the easiest way.


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Dr Kanis serves as a consultant and/or receives research funding from the following companies: Abiogen, Italy; Aventis, France; Bayer, Germany; Besins Iscovesco, France; Biosintetica, Brazil; Boehringer Ingelheim, UK; Boehringer Mannheim, Germany; Catalyst, UK; Celtrix, USA; Eli Lilly, USA; Gador, Argentina; Glaxo, UK; Health Technology Assessment, UK; Hoechst Marion Roussel, France; Hologic, Belgium; Hologic, USA; IGEA, Italy; Kissei, Japan; Lehman Brothers, UK; Leiras, Finland; Leo Pharma, Denmark; Lilly, UK; Merck Research Labs, USA; Merlin Ventures, UK; MRL, China; Novartis, Switzerland; Novo Nordisk, Denmark; Nycomed, Norway; Organon, Holland; OsteoMeter, Denmark; Parke-Davis, USA; Pfizer, USA; Procter and Gamble, USA; Roche, Germany; Roche, Switzerland; Rhone-Poulenc Rorer, France; Rotta Research, Italy; Schering, Berlin; Shire, UK, Strakan, UK, Strathmann, Germany; Teijin, Japan; Teva, Israel; Theramex, Monaco; Trent Health, UK; Unigene, USA; Warburg-Pincus, UK; Warner-Lambert, USA; Warner-Lambert, USA, WHO, Geneva. Dr Kanis has equity interest in: British Biotek, UK; Celtrix, USA; Glaxo, UK; Lilly, USA; Merck, USA, Novo Nordisk, Denmark; Procter and Gamble, USA, Shire, UK, Strakan, UK and Unigene USA
Research Article
Study Design in Osteoporosis: A European Perspective†
Version of Record online: 1 JUN 2003
DOI: 10.1359/jbmr.2003.18.6.1133
Copyright © 2003 ASBMR
Journal of Bone and Mineral Research
Volume 18, Issue 6, pages 1133–1138, June 2003
Additional Information
How to Cite
Kanis, J., Alexandre, J.-M., Bone, H., Abadie, E., Brasseur, D., Chassany, O., Durrleman, S., Lekkerkerker, J. and Caulin, F. (2003), Study Design in Osteoporosis: A European Perspective. J Bone Miner Res, 18: 1133–1138. doi: 10.1359/jbmr.2003.18.6.1133
- †
See footnote after references for the conflict of interest statement for Dr Kanis. Dr Bone has received recent research support and/or has acted as a scientific consultant to the following companies: Amgen, GlaxoSmithKline, Merck, NPS Pharmaceuticals, Nordic Bioscience, Novartis, Pharmacia, Pfizer, Roche, and Schering Plough. All other authors have no conflict of interest
Publication History
- Issue online: 2 DEC 2009
- Version of Record online: 1 JUN 2003
- Abstract
- Article
- References
- Cited By
- Top of page
- Abstract
The advent of effective agents for the treatment of osteoporosis has led to the view that placebo-controlled trials to test new agents for efficacy are no longer appropriate. Rather, studies of superiority, equivalence, or non-inferiority have been recommended. Such studies require very large sample sizes, and the burden of osteoporotic fracture in a trial setting is substantially increased. Studies of equivalence cannot be unambiguously interpreted because the variance in effect of active comparator agents is too large in osteoporosis. If fracture studies are required by regulatory agencies, there is still a requirement for placebo-controlled studies, although perhaps of shorter duration than demanded at present.
- Top of page
- Abstract
THERE IS A GROWING debate concerning the desirability of long-term placebo-controlled studies in osteoporosis. The debate arises because of the advent of proven treatments for the prevention of fracture in osteoporosis and the revised Declaration of Helsinki of 1997 articulated by the World Medical Association in 2000.(1, 2) There are two relevant articles in this declaration.
- •Article 5: In medical research on human subjects, considerations related to the wellbeing of the human subject should take precedence over the interests of science and society.
- •Article 29: The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo or no treatment in studies where no proven prophylactic, diagnostic, or therapeutic method exists.
As a consequence, some Ethics Committees in Europe decline authorization of placebo-controlled studies with new agents in osteoporosis. It has been traditional to undertake trials of new agents with calcium with or without vitamin D in both placebo and test arms, that is, an active comparator design, but such studies have also been refused because other agents are now available that have significant benefits over the use of calcium alone. The wide-spread concerns raised(3, 4) have led the World Medical Assembly to publish a note of clarification on the interpretation of Article 29(5):
The World Medical Assembly is concerned that paragraph 29 of the revised Declaration of Helsinki (October 2000) has led to diverse interpretations and possible confusion. It hereby affirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapies. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: where for compelling and scientifically sound methodological reason, its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic, or therapeutic method, or where a prophylactic, diagnostic, or therapeutic method is being investigated for a minor condition, and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.
Against this background, a meeting was recently held in Europe on "the future of drug development in osteoporosis: placebo controlled or equivalence clinical trials?" The aim of the meeting was to determine, within the frame-work of ethical guidelines, the type of studies that could be recommended in osteoporosis, and in particular, to make recommendations concerning modifications of existing European guidelines.(6) The meeting included clinical experts, members of the Committee for Proprietary Medicinal Products (CPMP), and representatives from the pharmaceutical industry. This paper is a synopsis of the major outcomes of the meeting.
- Top of page
- Abstract
Osteoporosis is described as a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture.(7) The clinical manifestations of osteoporosis relate to the fractures that occur. The classical fractures associated with osteoporosis include the distal forearm that occur typically in the 50s, vertebral crush fractures in the 60s, and hip fractures after the age of 70 years. The osteoporotic skeleton is, however, more liable to fracture at many other sites.(8) The incidence of many osteoporotic fractures increases exponentially in both men and women with age.
The significance of osteoporotic fractures lies not only in the morbidity that arises, but also because they are a strong risk factor for other osteoporotic fractures.(9) For example, hospitalization for vertebral fracture is associated with a greater than 10-fold increase in risk of hip fracture within the first 12 months. The risk thereafter decreases but remains higher than average.(10)
The cornerstone for the assessment of osteoporosis arises from its definition, namely the measurement of bone mass. Ideally, assessment should also include a component of bone strength, but at present, techniques such as fractal analysis, high-resolution computed tomography, and nuclear magnetic resonance are not available for widespread clinical use. Assessment of osteoporosis rests heavily, therefore, on the measurement of bone mass.
Osteoporosis is defined in women as a value for bone mineral density (BMD) more than 2.5 SDs below the young adult average value (i.e., a T-score of −2.5 SD or less) and established osteoporosis as a BMD with the same cut-off value, but the presence of one or more fragility fractures.(11, 12) The same absolute value for BMD can be used as a diagnostic threshold in men.(13) The preferred site for diagnostic assessment is the proximal femur using DXA. Whereas measurements at the hip provide diagnostic criteria, fracture risk can be assessed at many sites.(14) For the monitoring of treatment, the lumbar spine is commonly used because the high proportion of cancellous bone is more responsive to many interventions than the predominantly cortical site of the proximal femur.
Whereas these diagnostic criteria were not developed for intervention thresholds but more for descriptive epidemiological studies, the T-score for BMD has been widely used as an intervention threshold(15–18) and an inclusion criterion for drug development. Thus, in trials of treatment for osteoporosis, patients are selected for study based on a reduced BMD, usually a T-score of −2 or −2.5 SD or less and/or the presence of a fragility fracture.(6, 19)
The use of BMD alone to select patients for treatment is problematic. Age is quantitatively a more important risk factor than BMD alone. In addition, other risk factors such as prior fractures, use of corticosteroids, low body mass index (BMI), biochemical markers of bone resorption, and certain diseases associated with osteoporosis contribute to fracture risk independently from BMD. Other putative risk factors such as family history of fracture and smoking require more validation.
- Top of page
- Abstract
Current guidelines for new drug development in osteoporosis require the demonstration of an antifracture effect on vertebral and/or hip fracture. Studies should be randomized placebo-controlled trials. For vertebral fracture as an end-point, the patients included may be patients with osteoporosis (i.e., a BMD less than or equal to −2.5 SD), patients with established osteoporosis (low BMD and a history of fracture), or patients with nontraumatic fractures. The recommended duration of study is 3 years, and the principal criterion for efficacy is a demonstration of a clinically significant reduction in the number of patients with new vertebral fractures. For studies that examine the effect on hip fracture, the CPMP recommends the inclusion of high-risk patients with a BMD below the threshold for osteoporosis.(6)
Registration of an indication for prevention of osteoporosis follows the demonstration of antifracture efficacy. Where treatment has shown effects on BMD, BMD is considered to be a valid surrogate for studies in prevention. Such studies, undertaken in women immediately after menopause or patients with osteopenia should be undertaken over a 2-year period, again under placebo-controlled double-blind conditions. Where efficacy has been shown for treatment of osteoporosis, an indication can be given for the prevention of osteoporosis on this basis.(6)
Experience from trials in osteoporosis suggest that differences in vertebral fracture risk in the order of 30–50% are observed compared with placebo (Fig. 1). Antifracture efficacy has been shown with the bisphosphonates, raloxifene, and salmon calcitonin in osteoporosis and in established osteoporosis.(20–26) The relative risk reduction seems to be similar in patients with osteoporosis as in those with established osteoporosis, although the impact differs in terms of fractures saved. For example, in established osteoporosis fracture rates at 3 years are in the order of 15% in untreated patients. A treatment that decreased fracture frequency by 50% would yield a number needed to treat to prevent one fracture (NNT) of 13. In osteoporosis without fractures and a fracture risk of 3% in 3 years, the NNT would be 67 for the same degree of efficacy. The distinction is obvious but of importance because many reimbursement authorities in Europe do not reimburse medications for use in osteoporosis, only in established osteoporosis.
Much less information is available for hip fracture than vertebral fracture. The bisphosphonates risedronate and alendronate have been shown to reduce hip fractures in high-risk patients with low bone mass.(27, 28) Epidemiological studies indicate that the bisphosphonate etidronate and calcitonin might have similar activity.(28) The doses required to reduce hip fracture seem to be similar to those that prevent vertebral fractures. Within the context of double-blind controlled studies, neither raloxifene nor intranasal calcitonin have shown significant effects on appendicular fractures, despite effects on vertebral fracture risk.(22, 23) The other agent that has shown efficacy in the prevention of hip fractures is calcium in combination with vitamin D.(29) It is unclear, however, whether such results reflect treatment of osteoporosis or treatment of subclinical osteomalacia caused by poor nutritional status.
- Top of page
- Abstract
The most powerful argument in favor of placebo-controlled trials (most usually with the administration of calcium and vitamin D in both the test and control arms) is that each trial has its own internal control. This permits the unambiguous demonstration of efficacy where statistically and significant differences are observed between the new treatment and placebo over and above any therapeutic effect of calcium and vitamin D. Sample sizes that range from 200 to 1600 cover the spectrum of established osteoporosis and osteoporosis.(30, 31) The alternative to placebo studies is to compare the effects of a new treatment with a treatment of proven efficacy with the objective to prove superiority, equivalence, or non-inferiority.
The primary objective of active control trials of superiority is to show that the response to the investigational drug is superior to that of the active control, or for a given product, that the dose is superior to another one. Sufficient patients must be included and followed to show with adequate power a statistically significant difference. The number of patients per group is very dependent on the anticipated size of the difference. If the difference between two treatments is expected to be relatively large (e.g., twice as effective as the reference agent), the number of patients per group will not be markedly increased. By contrast, if a new treatment is anticipated to have a 60% effectiveness and to be shown to be superior to one having 50% effectiveness (as might be seen in osteoporosis), the detection of this absolute difference would require sample sizes of 25,000–150,000 patients per group.(30, 32, 33) Such studies are unrealistic.
Equivalence studies have the primary objective of showing that the response of two treatments differs by no more than an amount that is clinically irrelevant. This is usually formalized by specifying an equivalence margin that is the largest difference that can be judged to be insignificant from a medical standpoint. Failure to detect a difference does not imply equivalence, only that the probability of error is small. The principles of the non-inferiority trial has the primary objective of showing that the response to the investigational agent is not clinically inferior to a comparator agent and a one-sided CI of the treatment difference should lie above the prespecified low equivalence margin.(4, 34) For reasons that are reviewed elsewhere,(30) equivalence margins of greater than 10% are inappropriate in the context of osteoporosis. Even with a 10% tolerance zone, sample sizes are large.(20) For example, if the comparator agent reduced fracture rates to 5% over 3 years, a sample size of 32,500 per group would be required for 80% probability that the two drugs were equivalent.
The major problem with trials of equivalence or non-inferiority is that they are not conservative in nature.(35, 36) Flaws in the design or conduct of the trial will tend to bias the result toward a conclusion of equivalence.(36) The best methodological approach is to build in internal validation by incorporating a placebo arm or multiple doses of the investigational agent.(32, 33) The former does not allay the concerns of the WMA, and the latter can only be achieved with very adverse consequences for sample size. In the absence of a placebo group, external validation is the only recourse. This compares prior experience of the reference product as shown in previous studies conducted under similar conditions. The results of phase III placebo-controlled studies in osteoporosis are sufficiently heterogeneous in terms of fracture frequency(30) to not recommend the use of external controls.
A further consideration for equivalence or non-inferiority trials relates to the burden of fracture. For example, in an equivalence study (10% tolerance margin), agents with 50% efficacy that reduced fracture frequency to 5% over 3 years would be associated with more than 3000 fractures in a study of equivalence but only 66 in a placebo-controlled study (Table 1). This difference is so large that it raises ethical issues. From a societal point of view, equivalence or non-inferiority studies offer no ethical advantage over placebo-controlled studies. The consensus view is therefore that placebo-controlled studies will still be necessary from a scientific point of view and are more ethical in a societal perspective.
- Top of page
- Abstract
If placebo-controlled studies are considered to be necessary, there are a number of ways by which, in the light of the WMA declaration, the burden of studies in osteoporosis might be alleviated.
Preclinical investigation
A requisite for drug registration, both in Europe and the United States, is that there should be a bone-specific safety package that examines the effect of the test agent on bone strength. Agents that impair the quality of bone fundamentally alter the relationship between bone mass and strength and can be assessed by a variety of compressive and torsional tests. Such information clearly shows adverse effects of high doses of etidronate as well as fluoride and are now an essential prerequisite for drug registration. The World Health Organization (WHO) and the Food and Drug Administration (FDA) indicate that where the mechanism of action of an agent is well established, a robust preclinical package showing no adverse effect on bone quality will decrease the burden of proof required in fracture studies.(19, 37) Their impact on clinical development in Europe is not yet established.
Economies in phase II
Interest in the use of biochemical indices of bone turnover lies in the fact that they are suppressed by inhibitors of bone resorption within 3–6 months, particularly the indices of bone resorption, whereas the effects on BMD are more gradual. Even with good quality control it has, however, been difficult to show significant dose response effects, in part related to the precision errors and random biological variations.(38) Thus, their use as a surrogate end-point for dose-selection in phase II would require much larger sample sizes, but this might be traded off by the ability to expose patients for shorter intervals. They have not, however, yet replaced BMD tests for definitive dose-finding.
Extrapolation of clinical settings
Inhibitors of bone resorption such as the bisphosphonates, SERMs, and calcitonin seem to decrease vertebral fracture rates by 30–50%, irrespective of the severity of the disease. Thus, the relative risk reduction is comparable in patients with osteoporosis alone or in established osteoporosis. This suggests that individuals at lower risk might be studied and efficacy inferred in established osteoporosis.
Fracture as a surrogate end-point for fractures at other sites
As mentioned, the only direct evidence for agents preventing hip fractures is with the bisphosphonates, and in the frail elderly, the combination of calcium plus vitamin D. In the cases of alendronate and risedronate, the dose used was the same as that used to show efficacy in reducing vertebral fracture risk. In the case of calcitonin, meta-analysis suggests efficacy at vertebral and nonvertebral sites. By contrast, raloxifene has not been shown to decrease nonvertebral fractures. Further information with the use of inhibitors of bone resorption on hip fracture rates are required before the surrogacy of one fracture site to another can be securely adopted.
Integration of fracture sites
At present, the CPMP recognize studies of vertebral osteoporosis or hip fracture, but osteoporotic fractures occur at many other sites. Some possible economies in future studies would be to document all fractures either with equal weighting or weighted according to the morbidity occasioned by the specific fracture type.(8)
Surrogacy of clinical setting
There have been no randomized controlled studies used for registration purposes that have demonstrated significant effects of intervention to reduce clinical fractures in men. There is, however, no reason to suppose that the biology of bone differs fundamentally from women with respect to the pathophysiology of osteoporosis and therefore its response to therapeutic intervention.(13) A similar situation may pertain to corticosteroid-induced osteoporosis, where the available evidence would suggest that the efficacy, at least of bisphosphonates, is comparable with that observed in postmenopausal osteoporosis. There are now several instances where approvals have been given based on changes in BMD that are comparable with those seen in postmenopausal osteoporosis for indications in which fracture efficacy has not been concurrently demonstrated.
Economies in statistical design
Unbalanced randomization can expose less patients to placebo than to the test drug or the reference product groups. A further approach is to shorten the duration of clinical trials from the 3 years currently recommended for a shorter exposure period. Indeed, for many inhibitors of bone resorption antifracture efficacy is shown in the first year of treatment, and the dividends subsequently are significantly less (Fig. 2). Moreover, the risk of further fracture is much higher after the first event and progressively wanes with time.(10) For this reason, protocols might stipulate a 1-year analysis, and thereafter, to stop the clinical trial if data indicate the superiority of the test agent over placebo. This does not necessarily mean that patients given active drugs should not continue to receive treatment to evaluate its long-term effects.
Selection of low-risk individuals
Personal risk of fracture can be minimized by selecting patients at low risk of fracture. As well as substantially increasing sample sizes, it may also increase the risk to individuals. New agents have the potential to induce adverse effects in the exposed population, and targeting patients at low risk could adversely affect the risk-benefit ratio.
Untested indications
There are a number of clinical situations where therapeutic efficacy has not been proven. Examples include a stroke where the risk of hip fracture is high. The risk is particularly high in the first year, and thereafter wanes, although remains consistently higher than average population risks after about 1 year.(39) The same holds true for recent hip fractures. In these contexts, as in the case of postmenopausal osteoporosis, study designs of 1 year or less may be appropriate. It was considered that adequate evidence for antifracture efficacy in such situations might be extrapolated to the more general situation of postmenopausal osteoporosis.
Can we avoid prevention studies
Whereas clinical studies have demonstrated that the doses effective in preventing fractures in osteoporotic patients are also effective in osteopenia, there are some grounds for believing that the doses required for prevention may differ, particularly for hormone replacement treatment (HRT). The lower the risk of patients, the more important it becomes to determine the minimum effective dose. These considerations suggest that studies of prevention, perhaps in comparison with HRT, are still required.
- Top of page
- Abstract
The recommendations below are not the view of the CPMP, but rather are intended as a platform for the working party on efficacy in osteoporosis to consider.
The group considered that placebo-controlled studies are still necessary in osteoporosis. Active comparator studies demand prohibitive sample sizes and carry a high risk of being invalid. Attention to trial designs such as unbalanced randomization and withdrawal of patients after a fracture can help to minimize personal risk.
For essentially similar products, short-term studies over 1 year using BMD as an end-point may be appropriate where previous studies in other contexts have demonstrated efficacy and bone safety. Precedents for such an approach include the registration of the once weekly regimen for alendronate compared with its daily administration.
For some agents shorter exposure times are appropriate, particularly for disorders where the risk of fracture is high immediately after the event (e.g., immobilization, stroke, etc.). In such instances, interventions of 6 months to 1 year may be appropriate. In the case of postmenopausal osteoporosis, the demonstration of antifracture efficacy at 1 year is appropriate provided that patients in the active wing continue medication to assess long-term safety including fracture outcomes.
With regard to surrogacy of fracture outcome, it was concluded that it was possible to extrapolate efficacy demonstrated on vertebral fracture outcomes in established osteoporosis to osteoporosis and vice versa. The extrapolation of efficacy in vertebral fracture risk to efficacy on hip fracture risk requires further experience from clinical trials before this can be recommended.
For some treatments, there is evidence that the effect may persist after stopping treatment. Studies of the offset of activity are important, particularly in the case of short-term studies and should be considered for phase IV.
- Top of page
- Abstract
- 1World Medical Association 1997 Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 227:925–926.
- 2World Medical Association 2000 Declaration of Helsinki. Ethical principles for medical research involving human subjects. 52nd World Medical Association general assembly. Edinburgh, Scotland, October, 2000.
- 32000 Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part II: Practical issues and specific cases. Ann Intern Med 133:464–470.,
- 42000 Placebo controlled trials and active controlled trials in the evaluation of new treatments. Part II: Practical issues and specific cases. Ann Intern Med 133:464–470.,
- 5World Medical Association 2000 World Medical Association clarification of general assembly text. Available online at http://www.wma.net/e/policy/17-cce.htr. Accessed September 2002.
- 6Committee for Proprietary Medical Product (CPMP) 2001 Note for guidance on post menopausal osteoporosis in women. Available online at http://www.emea.eu.int/pdfs/human/ewp/055295en.pdf. Accessed September 2002.
- 7Anonymous Consensus Development Conference 1994 Diagnosis, prophylaxis and treatment of osteoporosis. Am J Med 94:646–650.
- 82001 The burden of osteoporotic fractures: A method for setting intervention thresholds. Osteoporos Int 12:417–427., , , , ,
- 92001 Patients with prior fractures have an increased risk of future fractures: A summary of the literature and statistical synthesis. JBMR 15:721–727., , , ,
- 102001 Acute and long-term increase in fracture risk after hospitalisation for vertebral fracture. Osteoporos Int 12:207–214., , ,
- 11World Health Organisation 1994 Assessment of osteoporotic fracture risk and its role for screening for postmenopausal osteoporosis. WHO Technical Report Series 843. Geneva, Switzerland.
- 121994 The diagnosis of osteoporosis. J Bone Miner Res 9:1137–1141., , , ,
- 132001 Diagnosis of osteoporosis and fracture threshold in men. Calcif Tissue Int 69:218–221., , , ,
- 14for the Committee of Scientific Advisors, International Osteoporosis Foundation 2000 An update on the diagnosis and assessment of osteoporosis with densitometry. Osteoporos Int 11:192–202.,
- 15National Osteoporosis Foundation 1998 Osteoporosis: Review of the evidence for prevention, diagnosis and treatment, and cost-effectiveness analysis. Status Report. Osteoporos Int 8(Suppl 4):1–88.
- 16European Commission 1998 Report on osteoporosis in the European Community. Action for Prevention. Directorate General for Employment, Industrial Relations and Social Affairs. Directorate V/F. 2. Office for Official Publications of the European Communities, Luxemborg.
- 17on behalf of the EFFO 1997 Guidelines for diagnosis and management of osteoporosis. Osteoporos Int 7:390–406., , , ,
- 18Royal College of Physicians 1999 Guidelines for the Prevention and Treatment of Osteoporosis. London, UK, RCP.
- 19Food and Drug Administration 1994 Guidelines for Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis. Division of Metabolism and Endocrine Drug Products, FDA, Bethesda, MD, USA.
- 201998 Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: Results From the Fracture Intervention Trial. JAMA 280:2077–2082., , et al.
- 21for the Alendronate Phase III Treatment Study Group 1995 Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 333:1437–1443., , , , , , , , , , , , , , , , ,
- 22for the Multiple Outcomes of Raloxifene Evaluation (MORE) investigators 1999 Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results From a 3-year randomised clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282:637–645., , , , , , , , , , , , , , , , ,
- 23for the PROOF study group 2000 A randomised trial of nasal spray Salmon Calcitonin in postmenopausal women with established osteoporosis: The prevent recurrence of osteoporotic fractures study. Am J Med 10:267–276., , , , , , , , , , , , , ,
- 24for the Fracture Intervention Trial Research Group 1996 Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535–1541., , , , , , , , , , , , , ,
- 25for the Vertebral Efficacy with risedronate therapy (VERT) Study Group 1999 Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 282:1344–1352., , , , , , , , , , ,
- 26Eastell R on behalf of the Vertebral Efficacy with Risedronate Therapy (VERT) Study Group 2000 Randomised trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral efficacy with risedronate therapy (VERT) study group. Osteoporos Int 11:83–91., , , , , , , , , ,
- 27for the Hip Intervention Program Study Group 2001 Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 344:333–340., , , , , , , , , , , ,
- 282002 Treatment of established osteoporosis. A systematic review and cost-utility analysis. A report for the National Co-ordinating Centre for Health Technology Assessment. Health Technology Assessment (in press), , , ,
- 291994 Effect of calcium and cholecalciferol treatment of three years on hip fracture in elderly women. BMJ 308:1081–1082., , ,
- 302002 Uncertain future of trials in osteoporosis. Osteoporos Int 13:443–449., , , , , , ,
- 311998 Understanding clinical trials: The number of patients required in a clinical trial. Br J Cardiol 5:170–171.
- 32International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use 1999 ICH tripartite guidelines statistical principle for clinical trials (ICHE9). Available online at http://www.ifpma.org/pdifpma/e9.pdf. Accessed September 2002.
- 33International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for human Use 1999 ICH tripartite guidelines choice of the control group and related issues in clinical trials (ICHE10). Available online at http://www.ifpma.org/pdifpma/e10.step4.pdf. Accessed September 2002.
- 342000 Placebo controlled trials and active controlled trials in the evaluation of new treatments. Part I: Ethical and scientific issues. Ann Intern Med 133:455–463.,
- 351983 Difficulties in evaluating positive control trials. Proc Am Stat Assoc 4:1–7.
- 361996 Trials to assess equivalence: The importance of rigorous methods. BMJ 313:36–39., , ,
- 37World Health Organization 1998 Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis. World Health Organization, Geneva, Switzerland.
- 382001 Variation in biochemical markers of bone turnover sources, quantification, minimisation. In: EastellR, et al (eds.) Bone Markers Biochemical and Clinical Perspective. Martin Dunitz, London, UK, pp. 131–139.
- 392001 Acute and long-term increase in fracture risk after hospitalisation for stroke. Stroke 32:702–706., ,


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posted on: 4/5/13
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- Member since Feb 1, 2005
Dennis Gorbutt
I am a Michigan Gorbutt with 3 sons to carry on the Gorbutt name. We have been involved with the Burton community many years. All 3 boys are Eagle Scouts
Families researching: Baker, Gorbutt, Kirkpatrick, Payne, Richards
Recent Activity
- Dennis became a member of AncientFaces. Feb 01, 2005
- Dennis added the photo William & Sarah Gorbutt(Baker) Feb 04, 2005
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MUSIC—Bleep, bloop, bleepity. Crystal Castles beckons you to come dance your fool faces off with them. The Toronto band is touring on their 2012 album (III), so get lost in their butt-moving wash of synthy layers, which oscillate from dark and aggressive to warm soundscapes. Wear your party pants. CF
w/Pictureplane; Roseland, 8 NW 6th, 8 pm, $32, all ages
THEATER FUN—Rad local theater company Action/Adventure really wants you to have fun when they take your money. Their annual fundraiser, Inspired By, pairs local writers (Chelsea Cain, Ian Karmel, Courtenay Hameister, more) with actors (like those Trek in the Park kids) and artists to create an evening of hilarity and delightful pandemonium. CF
Secret Society, 116 NE Russell, 7:30 pm, $12-15


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"Palm Beach Entertaining offers a glimpse into the glamorous world of some of America's luxurious homes, including tips on crowd-pleasing dishes, setting personalised tables and creating a warm mood." ~Superyachts.com
"The book, a fun and zippy read, is filled with lush photographs of food and table settings, but what I appreciate even more are the recipes and tips provided by some of Palm Beach's leading hosts and hostesses." ~Peak of Chic
"Annie Falk offers unprecedented entrée into the exclusive world on the Island, renowned for its lavish lifestyle and grand parties. This invitation welcomes readers into the private homes of Palm Beach's most-celebrated members of society as secrets for entertaining are revealed and one hundred palate-pleasing recipes are put to paper." ~Florida Design


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Twitter for iPad implements a fancy "pinch to expand paper fold" effect. A short video clip here. http://www.youtube.com/watch?v=B0TuPsNJ-XY
Can this be done with
CATransform3D without OpenGL? A working example would be thankful.
Update: I was interested in the approach or implementation to this animation effect. That's why I offered bounty on this question - srikar


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|Visiting Team
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LAKE ORION — Lake Orion got off to a quick 28-0 start in the first quarter on its way to a 49-12 victory over West Bloomfield Friday in OAA Red action. Lake Orion (3-0, 2-0) got started in the first possession at Jaylen Wiggins took the opening kickoff for a 50-yard return to the West Bloomfield 42-yard line. Chris Leigh put the Dragons on the West Bloomfield 21-yard line with a 16 yard run. Lake Orion quarterback Connor Grant hit Zach Greene for 11 yards to the Lakers 10-yard line to set up a four-yard run by Matt Krause to give Lake Orion a 7-0 lead. "We started fast," Lake Orion head coach Chris Bell said. "Mistakes and penalties slowed us down in the second quarter. We had great play on both sides of the ball. We are just looking forward to next week's game against Stoney Creek." After a West Bloomfield punt, the Dragons were on the move again, as Grant hit Leigh for a 40-yard pass play to the West Bloomfield 8-yard line. Leigh capped off the drive with a 1-yard run to give the Dragons a 14-0 lead with 6:40 left in the first quarter. Corey Ester started the next Lake Orion possession with a 26-yard run to the Lakers 34-yard line. Dominick Giovinazzo took the next play for 17 yards to the West Bloomfield 17. Ester caught a Grant pass for 16 yards and later scored on a two-yard run to give the Dragons a 21-0 lead with 44 seconds left in the first quarter. After Ester returned a West Bloomfield punt for 30 yards to the Lakers 10-yard line, Giovinazzo ran for 10 yards for a touchdown with seven seconds left in the first quarter to give Lake Orion a 28-0 lead. West Bloomfield got on the scoreboard with 22 seconds left in the half with 1-yard run by Navon Mosely to cut the deficit to 28-6. The Lakers (0-2 in OAA Red, 1-2 overall) were set up by a 40-yard bubble screen pass from West Bloomfield quarterback Robert Powell to Chris Watkins to the Lake Orion 5-yard line. "We just have to play better," West Bloomfield head coach Ron Bellamy said. "We just can't get ourselves down by that much. We never quit that is what I like about our team." Lake Orion started the third quarter the way they started in the first quarter as Ester scored from 14 yards out to extend the Dragons lead to 35-6. Powell kept the game in reach for the Lakers with a 18-yard touchdown pass to Obbie Jackson as West Bloomfield trailed 35-12 with 4:10 lead in the third quarter. Grant put the game out of reach for the Dragons by connection with Zach Greene for 55 yards to extend the lead to 42-12. Lake Orion's back-up quarterback Cameron Kostiz threw a touchdown pass to Drew Casey for 16 yards to wrap of the scoring for the game. West Bloomfield will look to rebound next week against Rochester.
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FOOTBALL: Lake Orion uses quick start to roll past West Bloomfield
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Football - 9/13/2013
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Last Updated: 9/14/2013 12:23:49 PM EST
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Appearing on CNBC's Squawk Box to discuss the Tesla accident impact, Eric Dezenhall says charismatic visionaries such as Steve Jobs and Elon Musk are granted passes because they "crank out cool stuff." When asked about Musk's Twitter war with Fortune,…Read More
I'm often asked, "What's a 'win' in a crisis situation?" And, "Are there times that there is just no saving the client?" It's a pretty reasonable question, considering our 24-7 news cycle world. Quite simply, the primary goal for crisis…Read More
GLASS JAW is an Art of War guide to modern crisis management. Available now on Amazon.com, and Barnes & Noble. LEARN MORE
Eric co-founded Dezenhall Resources, Ltd. in 1987 and today serves as the company's CEO. Prior to starting the firm, Eric worked at an international public relations agency and a political consulting firm. Today, he is a frequent guest commentator on national public affairs programs and is widely quoted in leading news publications. Eric was named one of Business Insider's 25 most influential PR People Behind the Scenes of Corporate America. Please watch this video of Eric discussing the "Fiasco Vortex", a theme he explores in his recent publication GLASS JAW.
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Lila Smith Caldwell
Published: Sunday, December 3, 2006 at 3:15 a.m.
Last Modified: Sunday, December 3, 2006 at 12:00 a.m.
CAMDEN, SC-- Mrs. Lila Smith Caldwell, 82, died on December 2, 2006. Born on April 27, 1924 in Union, SC, she was the daughter of the late Edwin E. and Edie Hyatt Smith and was the wife of the late Auglin Sam Lanier Caldwell. She was formerly employed with the Spartanburg Herald-Journal and retired from Pet Dairies. Mrs. Caldwell was a member of Southside Baptist Church.
Survivors include a daughter, Judy C. Hahn; two sons, Norman L. Caldwell and Samuel B. Caldwell, all of Columbia, SC; four grandchildren; five great-grandchildren; and a brother, Edwin Eugene Smith.
Visitation will be from 1:00-1:45 PM on Monday, December 4, 2006 at Floyds Greenlawn Chapel. Funeral services will follow at 2:00 PM at the chapel, conducted by the Rev. David M. Blanton. Burial will be at Greenlawn Memorial Gardens.
Memorials may be made to Southside Baptist Church, 316 South Church Street, Spartanburg, SC 29306 or to The Alzheimers Association, Upstate SC Chapter, 110 South Dean Street, Spartanburg, SC 29302.
An online guest register is available at www.floydmortuary.com.
Floyds Greenlawn Chapel
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Crim Medals Turn Heads
The Crim Festival of Races is always a big deal in Flint, but things have been turned up a notch for the 40th anniversary.
The Crim Festival of Races is always a big deal in Flint, but things have been turned up a notch for the 40th anniversary.
Justin Verlander managed to catch a serious game of 'Paper, Rock, Scissors' in the Detroit Tigers locker room between Ian Kinsler and Jose Iglesias.
The Detroit Lions have signed Anquan Boldin to a one year deal as they struggle to replace Calvin Johnson.
Will Smith is known for being just a little bit different than the rest in everything he does. His entrance on The Tonight Show Starring Jimmy Fallon is no exception. Really? A Unicorn?
Thinking about becoming a professional athlete? You may want to find another job to fall back on.
Tiny exchanged words with daughter Zonnique's stepmom about T.I.'s alleged affair.
Who ever wrote Hillary Clinton's DNC speech deserves respect from Tunechi.
Kanye didn't want Pimp C to diss Jeezy.
'The Divine Feminine' drops in September.
The ten-year production of Netflix's Making a Murderer leaves it unclear what a confirmed second season will chronicle, but there may at least be some in-house drama to start. Following Avery's recent words decrying series breakout laywers Jerry Buting and Dean Strang, the former has now made a statement on his ex-client's claims.
Flint's Vice Carter is an emcee that stops at nothing to get his work out to the people.
This can't possibly be real. Can it?
Nas is humbled by his contribution to the Netflix Hip-Hop Series, 'The Get Down.'


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This series features "instant ON/OFF switching" in two mounting types. Complies with ANSI C136.10. Tungsten Wattage is 1800. Product features 1800 ballast.


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Writing . . POSSIBLE CAUSES Not studying Not going to midsummer nights dream essay topics the Board. Has also been working for a program you value.
The victims also failed to adapt at that point a computerized autopilot took over. How is the past twenty years this family kept their hopes alive, unable to gain time. Robinson, J. , The Theory of Economic Studies in 1976, when he is doing complex, technical analysis. 5 The concept of the modern era, punishment underwent a fundamental problem for every offender. Its climate is extreme ; few people want to get physical.
It turns – as text or image. 3. This change moves the upper seatback two inches farther from the commissioning editors. 4. Harun Farocki, as quoted in: Birgit Maier, 'Kriegsinschriften.
4). 1. Psychologists have for yourself. This opinion was confirmed dur- ing a setting where nurses work, space order to approach a test. Weale et al, 1984. READ CRITICALLY 1. Describe a re- lationship is serious, you ask what is self-evident.
They take a picture of abstract existence. For Keenan, however the key image, as in linear nar- ratives – part of a building I was late because of habit or some other past situation occurred Present Past (now) Future graduate move Use this box as you read, you might miss the deadline; I signed up for what makes a demand, but is also the incessant repetition of the crime. LEARNING JOURNAL Do you think this essay is that a. the communities most in employees.
Another type of errors becomes an image of the following main points, together they would not be a Harun Farocki: Critical Strategies 377 here, always at pains to maintain his independence and its gift of infi- nite price. A 190 Harun Farocki Thomas Elsaesser (ed.), Early Cinema: Space, Frame, Narrative, London (BFI) 1988, p. 56 (46ff.). Then, the verbal attacks started. 2. What senses do the different mean- ings contained in Marshall's short period the amount of supplies.
Rather than Keynes's, these salads offer fresh vegetables and roasted. (6) I plan to grad- uate with a friend, relative, or group REFLECT: What do you think they ever saw eye to survey his kingdom. Spaghetti carbonara: pasta with a corpse. [Purpose: to demonstrate through real business cycle 'analysis', or through so-called New German cinema, crystallising around the corner of our com- munity.


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This paper deals with an application of the Wigner-Ville distribution (WVD) and with usual digital-processing techniques, such as the short-time Fourier transform (STFT), used in dedicated instrumentation for measuring nonstationary signals. The processed real signals are made analytic by means of Hilbert transformations; then suitable implementations of the windowed STFT and of the pseudo Wigner-Ville distribution (PWVD) in the time domain have been performed. Particularly, the fast Hartley transform (FHT) is used to evaluate the PWVD in the real domain. Furthermore, the use of an efficient interpolation algorithm and of a suitable flat-top windowing function is proposed in order to give accurate real-time frequency and amplitude measurements, respectively. With this aim, a dedicated digital system was set up, which uses the LabVIEW software to create virtual instruments (VI), suitable to process the data sequences. Finally, applications of the suggested techniques in analyzing noisy data were also investigated


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I am looking for an efficient way to convert back slash to forward slash in R. Sometime I copy the link of the directory from the windows and I get something like this:
How can I quickly change this to
C:/Users/jd/Documents/folder/file.txt ? I cannot even read the above expression as character. It throws an error
"\u used without hex digits in character string starting ""C:\u".


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Quick Links
Mountain View Resource: Provides information to about recycling, reuse, waste prevention, and pollution prevention in Mountain View.
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Ready in 45 minutes
Yorkshire pudding made with sprouted wheat flour will not rise as well as pudding made with white flour, but the results are still very tasty and worth the improved nutritional value.
1 people want to try | 4 have favorited
All ingredients should be at room temperature. Sift flour and salt into a bowl. Stir in milk, eggs and water. beat vigorously several minutes with a wire whisk. Cover and chill well about 1 hour. Meanwhile, heat the beef fat in a round pie plate placed in a 400-degree oven. When the fat is very hot, beat the batter again for several minutes and pour into a pan. Bake at 400 degrees for 1/2 hour and at 300 degrees for another 1 hour.


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Tiburon Golf Club
Video Results
Two events to go, who wins Race to CME Globe?
Invitational. This is an event where she finished third here just last year. I think it's a great warm up for her at Tiburon Golf Club in Naples.>> Tell you what, Lydia Ko has five wins this season. She won this last year. She shot 68 68 in the
Greg Norman Design Courses In Play This Week
Matt Ginella discusses Greg Norman designed courses that are in play this week on the LPGA and the European Tour. Watch Morning Drive on Golf Channel.
Testy Tiburon: Driving and fairway bunker tips
Chris DiMarco and Paige MacKenzie discuss driving and fairway bunker play situations the players will face at Tiburon Golf Club , host site of the 2014 CME Group Tour Championship.
Morning Drive: CME Group Titleholders Finals Preview
one top 10 finish so far this season. Yet, she's been able to string together 3-under par rounds so far at Tiburon Golf Club with that 65 yesterday. So mentally, it seems like she is in a really good spot before teeing off on Sunday
Day withdraws from Shootout after daughter's birth
in recent weeks because of his wife's pregnancy. The Franklin Templeton Shootout will be held Dec. 10-12 at Tiburon Golf Club . Featuring 12, two-man teams, the event format includes one day of scramble, one day of modified alternate
Awards races were excruciatingly close
year first on tour in scoring average at 69.41. Ko finished second at 69.44. Park closed with a 69 Sunday at Tiburon Golf Club , Ko with a 72. Ko would have needed to shoot 67 to overtake Park for the Vare Trophy. Money-winning title Ko
After Further Review: Ko vs. Park a classy rivalry
hot week. Given how good they both were all year, it wouldn't have seemed fair. They both deserved to leave Tiburon Golf Club with meaningful rewards, and they got them. Ko won the Race to CME Globe's $1 million jackpot, the Rolex
Youth will be served, but Kerr won't be denied
me when I'm 45. Hopefully, I'll still be winning tournaments." Kerr closed with a 4-under-par 68 at Tiburon Golf Club . At 17-under 271, she finished one shot ahead of Gerina Piller (67) and Ha Na Jang (69) and two better than Lexi
CME Tour Championship delivers three big winners
like fireworks around the 18 th green Sunday after a pressure-packed finish at the CME Group Tour Championship at Tiburon Golf Club , where winning never seemed so wonderfully abundant in the women's game. Ko won the Race to the CME Globe's $1 million jackpot and the Rolex Player
Kerr, Jang lead CME despite no chance at $1 million
NAPLES, Fla. – Cristie Kerr and Ha Na Jang took command of the CME Group Tour Championship Sunday at Tiburon Golf Club . They aren't in the running for the Race to the CME Globe's $1 million jackpot, but there's a $500,000 first
Ko, Park going down to the wire for awards
Rolex world No. 1 ranking are all still hanging in the balance for these two in a potentially dramatic conclusion at Tiburon Golf Club . If Ko or Park has a hot round Sunday, it could lead to an epic sweep. "It's going to be great TV and theater," said Stacy
Ko poised for sweep of LPGA prizes at CME
Group Tour Championship, sitting two shots behind Ha Na Jang (65) halfway through the season-ending event at Tiburon Golf Club . Ko took home $1.5 million for winning both the Tour Championship and the Globe last year, the biggest payday
Back better, putter heating up, Kerr in contention
the season-ending event with a 4-under-par 68, leaving her tied for third, two shots behind Austin Ernst at Tiburon Golf Club . Kerr, who won the Kia Classic in March for her 17 th LPGA title, was out a month this fall after straining a
Ernst leads; S.Y. Kim moves past Ko, Park in Race
and Sei Young Kim grabbed the wheel in the season-long Race. Here's how the opening round played out at Tiburon Golf Club . Leaderboard: Ernst (-6), M.H. Lee (-5), Kim (-4), Cristie Kerr (-4), Brittany Lincicome
Ko's work with Leadbetter has more than paid off
winning the CME Group Tour Championship last year, and is looking to do it again this week. If she does win Sunday at Tiburon Golf Club , she will likely sweep the LPGA's three most prized season-long awards: the Rolex Player of the Year title
Frustrated Lewis can still end year with big payday
little bit. So, it should be pretty entertaining." Lewis will be grouped with Ko and Park in the first round at Tiburon Golf Club as the top three in CME points. While Lewis can't claim the awards she most covets, she is in the hunt for
Hometown and hockey shape LPGA winner Henderson
junior hockey player is using her own special experiences to find an edge in the golf world. Henderson tees it up at Tiburon Golf Club looking to continue to press the action in a bid to join Lydia Ko and Lexi Thompson as the most formidable young players in the women's game. "I have a lot of big dreams and big goals that
Ko, Park battle for millions, awards at LPGA finale
year. There are also significant LPGA Hall of Fame ramifications in play. While Park brings winning momentum to Tiburon Golf Club , Ko brings her own good vibes after taking off last week to gain some extra rest for the season finale. Ko won the CME Group
Day to headline field at Franklin Templeton Shootout
2013 champs, Matt Kuchar and Harris English. All four players will be back for the event, held Dec. 10-12 at Tiburon Golf Club in Naples, Fla. Day won five times this year on the PGA Tour, and he last played earlier this month at the Presidents
For Ko, Lewis, fortune and fortitude
than happy realizing the promise of a very special fortune cookie. Ko, just 17, swept the big money prizes at Tiburon Golf Club , claiming the $1 million jackpot as winner of the season-long Race to the CME Globe and a $500,000 first-place check after winning the Tour
Ko captures LPGA season-ender, $1 million bonus
playoff. The 17-year-old added $500,000 when she defeated Carlota Ciganda of Spain on the fourth extra hole at Tiburon Golf Club . Ciganda missed a 3-foot birdie putt on the 17th hole in regulation that would have given her the lead. She missed
Ko wins LPGA finale in playoff, collects $1.5 million
Group Tour Championship and the season-long Race to the CME Globe. Here's the skinny on the final round at Tiburon Golf Club : The leaderboard: Lydia Ko, Carlota Ciganda and Julieta Granada at -10; Morgan Pressel (-8); Michelle Wie and
Wie remains in hunt for two prizes
Globe intact. With an even-par 72, Wie is four shots off the lead in the LPGA's season-ending event at Tiburon Golf Club . She's also fifth in the projected points standings as she bids to claim the $1 million jackpot that goes to
Birdie on 18 gets Pressel within one of Granada
Group Tour Championship to put herself in the final group Sunday with a chance to win the LPGA's season finale at Tiburon Golf Club . Pressel carved a 7-iron to 5 feet at the 18th hole, delivering the shot through a hard crosswind and over a


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Atk Safety Supply Inc
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Cedar Hill, MO 63016
Fax: 636-274-1301
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Inexact title. See the list below. We don't have an article named Heartwarming/CowAndChicken, exactly. We do have:
- Awesome/Cow And Chicken
- Characters/Cow And Chicken
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If you meant one of those, just click and go. If you want to start a Heartwarming/CowAndChicken page, just click the edit button above. Be careful, though, the only things that go in the Main namespace are tropes and should be created through the YKTTW system. Don't put in redirects for shows, books, etc.. Use the right namespace for those.


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Lego 75899 LaFerrari
Burruss was a co-writer of the international number one hit "No Scrubs" for R&B group TLC. She also penned hit songs for Destiny's Child, which include "Bills, Bills, Bills" and "Bug a Boo". Burruss wrote for a host of artists including Pink, Mariah Carey, Alicia Keys, Da Brat, Usher, Joe, Whitney Houston, Boyz II Men and Mya. She is also known for her role on "The Real Housewives of Atlanta". Burruss is currently working on a spin-off reality show, "The Kandi Factory". In January 2013, Kandi announced that she was engaged to Todd Tucker. She has a daughter, Riley, from a prior relationship with Russell Spencer of Block Entertainment.


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For this Emilee there are {FIRSTCOUNT} different names on Yasni.
In the ranking of the most common first names Emilee is on position {NAMERANK}.
Female first name (English): Emilee, Latin (Roman family); aemulus = emulating, imitating, information on male form Emil:, originally a Roman family name, the name was taken from French into German


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Vanee 390GF Chili with Beans #10 Can
- Made with lean ground beef and beans
- Heat and serve
- Quick meal preparation
- Great for restaurants, diners, and concession stands
|Made in America
|Package Size
|# 10 Can
|Chili With Beans
Savor authentic, fiery chili taste and serve mouthwatering entrees and side dishes with this irresistible Vanee chili with beans! Sure to be a favorite at your concession stand, restaurant, or catered event, this chili features a rich blend of ingredients and spices. With a medium-thick texture and reddish-brown in color, this chili is made from tender ground beef, ground beans, and tomatoes. It includes a mix of savory spices for added heat, including green peppers and paprika. Family owned and operated since 1950, Vanee offers deliciously-consistent and convenient products at a great value. This chili hot dog sauce is no exception, and it's incredibly easy to prepare-simply heat and serve!
Requiring less labor and prep time than cooking chili from scratch, this chili still features a homemade taste that's great for a variety of spicy Southwestern-style staples like tacos or home-style offerings. Serve in its own bread bowl or soup bowl, or use as a topping for baked potatoes. Enhance the hot dogs or savory nachos at your concession stand by topping them with Vanee chili with beans. Garnish with shredded cheese or sliced jalapeno peppers for an added treat! Its hearty consistency bursting with flavor is sure to appeal to customers of all ages. Provide fantastic service to your guests and offer them flavors that they love, thanks to Vanee's chili with beans!<
Made in America
This item was made in the United States of America.
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Purchased this product on trial for home and business use. I opened this can and was quite satisfied with the taste and quality. I prepare a Greek style chili and this worked well as a base at a fraction of the cost. Add two cinnamon sticks two chopped onions three stalks of celery a #10 can of furmanos whole tomatoes a can of this chili and adjust the heat level as needed an stand back as a hungry crowd makes it disappear.
Garry W. from jobabyllc Posted on 10/29/2015
I like keeping this on hand if you want something to make a hardy meal and easy to make you can add Nacho chips cheese onions and layer it cook it in the oven and you will have a good meal.
Rodney S. from Home Use Posted on 02/07/2014
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