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STICKDOKU BY TERRY STICKELS
Use your logic to find the correct number for each square. When finished,
all nine rows across, all nine columns down and all nine 3-by-3 boxes must
contain all nine numbers, 1 through 9, with no repeats.
1 7 1 8 1 1 6 1 I T
8 6 7_
_8 2 5 6_
7_ 2
_1 9 7__3_
_2 1 6
i a
7 5 3
Difficulty level: Easy (Answers below)
Print a larger version at usawcekendxom.
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FRAME GAMES
BY TERRY STICKELS
Can you solve these puzzles? Each
communicates a well-known saying,
person, place or thing.
Answers below.
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Geriatric Use
A total of 654 subjects m double-blind, placebo
controlled. efficacy trials who received ROZEREM
were at least 65 years of age; of these. 199 were
75 years of age or older No overall differences in
safety or efficacy were observed between elderly
and younger adult subjects.
ADVERSE REACTIONS
Overview
The data described in this section reflect exposure
to ROZEREM in 4251 subjects, including 346 exposed
for 6 months or longer, and 473 subjects for one year.
Adverse Reactions Resulting in Discontinuation
of Treatment
Six percent of the 3594 individual subjects exposed
to ROZEREM in clinical studies discontinued treat
ment owing to an adverse event compared with
the 2% of the 1370 subjects receiving placebo. The
most frequent advetse events teadng to decontmuation
in subjects receiving ROZEREM were somnolence
(0.8%), dizziness (0.5%). nausea (0.3%), fatigue
(0.3%). headache (0.3%), and insomnia (0.3%).
ROZEREM Most Commonly Observed Adverse
Events in Phase 1-3 trials
The incidence of adverse events during the Phase
1 through 3 trials!% placebo. n=1370; %
rametteon [8 mg], n=1250) were: headache NOS
(7%, 7%). somnolence (3%. 5%). fatigue (2%. 4%),
dizziness (3%, 5%), nausea (2%, 3%), insomnia
exacerbated (2%. 3%), upper respiratory tract
infection NOS (2%. 3%). dianhea NOS (2%, 2%).
myalgia (1%, 2%). depression (1%. 2%). dysgeusia
(1%, 2%). arthralgia (1%, 2%). influenza (0.1%),
blood cortisol decreased (0.1%).
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed
in the clinical trials of a drug cannot be directly
compared to rates in clinical trials of other drugs,
and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials
does, however, provide a basis for identifying the
adverse events that appear to be related to drug
use and for approximating rates
DRUG ABUSE AND DEPENDENCE
ROZEREM is not a controlled substance
Human Data: See the CLINICAL TRIALS section,
Studies Pertinent to Safety Concerns for Sleep-
Promoting Agents, in the Complete Prescribing
Information.
Animal Data: Rametteon did not produce any signals
from animal behavioral studies indicating that the
drug produces rewarding effects. Monkeys did not
self-administer rametteon and the drug did not
induce a conditioned place preference in rats.
There was no generalization between rametteon
and midazolam. Rametteon did not affect rotorod
performance, an indicator of disruption of motor
function, and it did not potentiate the ability of
diazepam to interfere with rotorod performance.
Discontinuation of rametteon in animals or in humans
after chronic administration did not produce
withdrawal signs. Rametteon does not appear to
produce physical dependence.
OVERDOSAGE
Signs and Symptoms
No cases of ROZEREM overdose have been reported
during clinical development
ROZEREM was administered in single doses up to
160 mg in an abuse liability trial. No safety or
tolerability concerns were seen
Recommended Treatment
General symptomatic and supportive measures
should be used, along with immediate gastric
lavage where appropriate. Intravenous fluids
should be administered as needed. As in all cases
of drug overdose, respiration, pulse, blood pressure,
and other appropriate vital signs should be moni
tored, and general supportive measures employed.
Hemodialysis does not effectively reduce exposure
to ROZEREM. Therefore, the use of dialysis in the
treatment of overdosage is not appropriate.
Poison Control Center
As with the management of all overdosage, the
possibility of multiple drug ingestion should tie
considered. The physician may contact a poison
control center for current information on the
management of overdosage
Rx only
Manufactured by.
Takeda Pharmaceutical Company Limited
540-8645 Osaka. JAPAN
Manufactured in:
Takeda Ireland Ltd.
Kilruddery. County Wicklow. Republic of Ireland
Marketed by
Takeda Pharmaceuticals America. Inc.
One Takeda Parkway
Deerfield. IL 60015
ROZEREM™ is a trademark of Takeda
Pharmaceutical Company Limited and used under
license by Takeda Pharmaceuticals America, Inc.
02005. Takeda Pharmaceuticals America. Inc.
05-1124 Revised: Apr. 2006
L-RAM-00035
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